[README.TXT File - OCTOBER 2010] ARCOS NDC DICTIONARY FILE/RECORD LAYOUT FIELD NAME LENGTH STARTING ENDING COLUMN COLUMN NDC 11 1 11 Ingredient Key 1 12 12 E77-Flag (DEA Use Only) 1 13 13 No. Ingredients 1 14 14 CSA Schedule 2 15 16 UN Schedule 1 17 17 Psychotropic Sched 1 18 18 Trade/Product Name 36 19 54 Package Quantity 9 (999999V999) 55 63 Package Measure 5 64 68 Drug Code 8 69 76 Salt Code 4 77 80 Ingredient Name 51 81 131 Ingredient Base Weight 13 (999999V9999999) 132 144 Field Name Descriptions 1. NATIONAL DRUG CODE (NDC) For ARCOS reporting purposes each drug product containing a controlled drug substance is identified as a unique 11-digit, three segment number. This number (i.e., acronym NDC) identifies the labeler/vendor, product and trade package size. The first segment, i.e., the LABELOR CODE, is assigned by the Food and Drug Administration (FDA). A labeler is any firm that manufacturers, distributes or repacks/relabels a drug product. The second segment, the PRODUCT CODE, identifies the name of the product, it's active ingredients, name of its manufacturer or private label distributor, strength, dosage form and formulation (i.e.,size, shape, color or code imprint (if any), and any other characteristic that identifies the product as unique. The third segment, the PACKAGE CODE, identifies package sizes (i.e., 12's, 24's, 100's for tablets, capsules, ampules and 30ml, 100ml, 8 fluid ounces, pint, gallon for liquid formulations) and package types (i.e., box, bottle, vial, etc.). EXAMPLE: ARCOS NATIONAL DRUG CODE CONFIGURATION LLLLL -- The first five digits represent the FDA assigned LABELER for a manufacturer, distributor or repacker/relabeler. PPPP -- The next four positions represent the PRODUCT CODE . The PRODUCE CODE designation is developed by the specific labeler (i.e.manufacturer, distributor, repacker/relabeler). KK -- The final two positions, also developed by the specific labeler, identifies the PACKAGE CODE. For ARCOS reporting, two general types of package code designations are identified as follows: 1. Any two-digit alphanumeric combination identifies a NDC product of a designated package size and type (i.e., bottle of 100 tablets/capsules or a pint bottle). 2. All other NDC products containing two asterisks (i.e., **) in the package drug code represent products that are:(a) bulk, raw, non-formulated controlled substances (i.e., usually bulk powders) or (b) bulk formulated products identified as a per unit value (i.e., 10mg codeine phosphate per tablet/capsule or 1mg hydrocodone bitartrate/ml) See file layout example of NDC# 585210032** below (i.e., positions 1-11). FILE POSITIONS 1 11 585210032** 585210032** 585210032** 585210032** 2. INGREDIENT KEY The Ingredient Key represents a number that identifies a unique controlled substance within a designated NDC number. In some instances, a unique NDC number may contain two or more controlled substances. As an example, the drug product, NDC#585210032**, trade name "ADDERALL", contains four unique controlled substances and is listed in the ARCOS NDC File as follows. NOTE: File Position 12 represents location of the Ingredient Key Number. See example below: FILE POSITIONS 1 11 12 585210032** 1 585210032** 2 585210032** 3 585210032** 4 3. E77-Flag (DEA Use Only) The E77-Flag located in position 13 of the NDC file layout identifies the controlled substance as a psychotropic substance in Schedules III and IV,i.e., CFR 1304.33(d)(i)(ii). Correlation of this information with types of manufacturing transactions aids in the determination of acceptance/ rejection of an ARCOS manufacturing transaction. In the example shown below, the NDC file layout does not contain any character in position 13. This indicates that the controlled substances identified in the NDC product are not listed in Schedules III & IV as cited in 21 CFR 1304.33(d)(i)(ii). FILE POSITIONS 1 11 12 13 585210032** 1 585210032** 2 585210032** 3 585210032** 4 4. NO. of INGREDIENTS The No. of Ingredients field of information located in position 14 of the ARCOS file layout identifies the total number of controlled substances contained in a unique NDC number. As an example, the drug product "ADDERALL"; NDC#585210032** contains four controlled substances, i.e., d-amphetamine saccharate, dl-amphetamine aspartate, d-amphetamine sulfate dibasic and dl-amphetamine sulfate dibasic. See example below: FILE POSITIONS 1 11 12 13 14 585210032** 1 4 585210032** 2 585210032** 3 585210032** 4 5. CSA SCHEDULE The Controlled Substance Act (CSA) Schedule number located in positions 15-16 of the ARCOS file layout identifies the particular CSA Schedule that has been assigned to the drug product containing a controlled substance/substances. Current CSA Schedules for various controlled substances are cited in 21 CFR Part 1308. NOTE: The requirements for ARCOS reportable controlled substances are cited in 21 CFR 1304.33(a)(b)(c)(d)(e)(f). In the example below, the designation of "2N" in positions 15-16 indicates that the controlled substance is a CSA Schedule 2 (i.e., Position 15) and a non-narcotic(i.e., Position 16). NOTE: A blank space in Position 16 indicates that the controlled substance is a narcotic substance. FILE POSITIONS 1 11 12 13 14 15-16 585210032** 1 4 4 2N 585210032** 2 4 585210032** 3 4 585210032** 4 4 6. UN SCHEDULE NUMBER The UN Schedule number located in position 17 of the ARCOS NDC file layout identifies the controlled substance as a narcotic substance which is controlled , scheduled and listed under the terms of the Single Convention on Narcotic Drugs, 1961 as amended by the Protocol of 25 March 1972. A list of narcotic drugs under international control is periodically updated by the International Narcotics Control Board (INCB), Vienna International Centre, P.O. Box 500, A-1400, Vienna, Austria. The INCB lists narcotics in Schedules I, II, III or IV. In the example below, position 17 is a blank space indicating that the controlled substance is not a narcotic substance as identified by the INCB. FILE POSITIONS 1 11 12 13 14 15-16 17 585210032** 1 4 4 2N 585210032** 2 4 585210032** 3 4 585210032** 4 4 7. PSYCHOTROPIC SCHEDULE NUMBER The Psychotropic Schedule number located in position 18 of the ARCOS NDC file layout identifies the CSA controlled substance as a psychotropic controlled substance which is controlled, scheduled and listed under the terms of the Convention on Psychotropic Substances 1971. A list of psychotropic drugs under international control is periodically updated by the International Narcotics Control Board (INCB), Vienna International Centre, P.O. Box 500, A-1400 Vienna, Austria. The INCB lists Psychotropic Substances in Schedules I, II, III or IV. In the example below, position 18 is filled with the number "2" for each of the four CSA controlled substances cited for NDC#585210032**, indicating that each of the controlled substances are identified and listed as psychotropic substances under international control in Schedule II of the Convention on Psychotropic Substances 1971. FILE POSITIONS 1 11 12 13 14 15-16 17 18 585210032** 1 4 4 2N 2 585210032** 2 4 2 585210032** 3 4 2 585210032** 4 4 2 8.TRADE/PRODUCT NAME The drug or product name located in positions 19-54 of the ARCOS NDC file layout attempts to list the trade or product drug name assigned by the manufacturer or labeler. In the example below, there is one trade name product (i.e., ADDERALL) that contains each of four CSA controlled substances. All trade names in the ARCOS NDC dictionary have been limited to 36 characters. Consequently, minor editorial changes have been made (i.e., abbreviations) for trade name products exceeding a length of 36 characters. In the example cited below, by convention, the trade name is listed, only once, next to the first ingredient. FILE POSITIONS 1 11 12 13 14 15-16 17 18 19----------------54 585210032** 1 4 4 2N 2 ADDERALL 10MG TAB 585210032** 2 4 2 585210032** 3 4 2 585210032** 4 4 2 9.PACKAGE QUANTITY The Package Quantity numbers located in positions 55-63 of the ARCOS NDC file layout, with an implied decimal point after character 60, represent the number of units contained in the package size of the NDC product. In the example cited below, a package unit of one (i.e., 1) is represented as 000001000. FILE POSITIONS 1 11 12---54 55-----63 585210032** REFER 000001000 585210032** TO 585210032** 2-8 585210032** ABOVE 10. PACKAGE MEASURE The package measure field of input located in positions 64-68 of the ARCOS NDC file layout identifies the unit of dosage form used to describe the trade package (i.e., ml, fl oz, mg, gm, kg, tablet, capsule, vial, ampule, etc.).In the example cited below, the package measure for the product "ADDERALL" is a tablet. FILE POSITIONS 1 11 12---54 55-----63 64-68 585210032** REFER 000001000 TAB 585210032** TO 585210032** 2-8 585210032** ABOVE 11. DRUG CODE The Drug Code field of input located in positions 69-76 of the ARCOS NDC file layout represents an eight-character DEA drug code numbering system for identifying all controlled substances. The first four characters of the drug code corresponds to that portion of the controlled substance molecule identified as the "base" drug. These four characters represent the DEA drug code assigned to each of the various controlled drug substances listed in 21 CFR Section 1308. Note, however, that 21 CFR Section 1308 is not a complete listing of all possible drug codes contained in the dictionary. Based upon the chemical configuration of the controlled substance, the fifth character is represented by either a period symbol "." or one of the following three characters: "B,D,L." The purpose of the fifth character is to aid (1)in the identification of the controlled substance as a base drug, salt of a base drug or derivative of a base drug and, where appropriate, (2)in terms of its optical activity (i.e., B=dl, racemic mixture;D=d, dextrorotatory; L=l, levorotatory). The last three characters, referred to as the "extension", identifies the controlled sub- stance as a base drug, a particular salt of the base drug or a derivative of a base drug. All extensions designated as ".000" identify the controlled substance as the base drug.Examples of other extensions are: 005=hydro- chloride; 009=sodium salt; 050=aspartate; 163=fumarate. In the example below, four unique eight-character drug codes are listed for each controlled sub- stance contained within the drug product "ADDERALL." FILE POSITIONS 1 11 12---54 55-----63 64-68 69----76 585210032** REFER 000001000 TAB 1100D330 585210032** TO 1100B050 585210032** 2-8 1100D010 585210032** ABOVE 1100D010 12. SALT CODE The Salt Code field of input located in positions 77-80 of the ARCOS NDC file layout represent a four-digit drug code that uniquely identifies the controlled substance as it exists in the NDC product. In the example below, four unique four-digit drug codes are cited for each of the controlled substances contained in the drug product "ADDERALL." FILE POSITIONS 1 11 12--54 55-----63 64--68 69----76 77-80 585210032** REFER 000001000 TAB 1100D330 1109 585210032** TO 1100B050 1113 585210032** 2-8 1100D010 1200 585210032** ABOVE 1100D010 1212 13. INGREDIENT NAME The Ingredient Name field of input located in positions 81-131 of the ARCOS NDC file layout cites the chemical name of the controlled substance contained in the NDC product. It should be noted that each controlled substance has a unique eight digit drug code and a four-digit drug code assigned to it. In the example below, the four chemical ingrdient names for each of the controlled substance contained in the drug product "ADDERALL" is listed. FILE POSITIONS 1 11 12---80 81-------------------------131 585210032** REFER d-Amphetamine Saccharate 585210032** TO dl-Amphetamine Aspartate 585210032** 2-12 d-Amphetamine Sulfate Dibasic 585210032** ABOVE dl-Amphetamine Sulfate Dibasic 14. INGREDIENT BASE WEIGHT The thirteen character Ingredient Base Weight field of input located in positions 132-144 of the ARCOS NDC file layout, with an implied decimal point after character six, represents the total weight (calculated in grams of base drug), of the controlled substance contained in the NDC product. In the example below, the ingredient weights for each of the four controlled substance contained in the drug product "ADDERALL", calculated in terms of grams of base drug, are listed. FILE POSITIONS 1 11 12---80 81-----------------------131 132--------144 585210032** REFER d-Amphetamine Saccharate 0000000009787 585210032** TO dl-Amphetamine Aspartate 0000000125978 585210032** 2-12 d-Amphetamine Sulfate Dibasic 0000000018345 585210032** ABOVE dl-Amphetamine Sulfate Dibasic 0000000018345