Home NDC 52959-003 Acetaminophen And Codeine
Product NDC 52959-003
11-digit product format 529590003
Labeler code 52959
Product ID 52959-003_75c9fa2e-a170-69f7-e053-2a91aa0ad11a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acetaminophen and codeine phosphate
Dosage form TABLET
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA089805
Marketing category ANDA
Marketing start 1988-09-30
Marketing end 0000-00-00
Substance CODEINE PHOSPHATE; ACETAMINOPHEN
Active strength 30 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52959-003-30 Theracodeine-300 30 in 1 BOTTLE TABLET 30 300 mg 7 52959-003-00 Acetaminophen And Codeine 100 in 1 BOTTLE, PLASTIC TABLET 100 4 52959-003-02 Acetaminophen And Codeine 120 in 1 BOTTLE, PLASTIC TABLET 120 4 52959-003-04 Acetaminophen And Codeine 4 in 1 BOTTLE, PLASTIC TABLET 4 4 52959-003-06 Acetaminophen And Codeine 6 in 1 BOTTLE, PLASTIC TABLET 6 4 52959-003-10 Acetaminophen And Codeine 10 in 1 BOTTLE, PLASTIC TABLET 10 4 52959-003-12 Acetaminophen And Codeine 12 in 1 BOTTLE, PLASTIC TABLET 12 4 52959-003-14 Acetaminophen And Codeine 14 in 1 BOTTLE, PLASTIC TABLET 14 4 52959-003-15 Acetaminophen And Codeine 15 in 1 BOTTLE, PLASTIC TABLET 15 4 52959-003-16 Acetaminophen And Codeine 16 in 1 BOTTLE, PLASTIC TABLET 16 4 52959-003-20 Acetaminophen And Codeine 20 in 1 BOTTLE, PLASTIC TABLET 20 4 52959-003-24 Acetaminophen And Codeine 24 in 1 BOTTLE, PLASTIC TABLET 24 4 52959-003-25 Acetaminophen And Codeine 25 in 1 BOTTLE, PLASTIC TABLET 25 4 52959-003-28 Acetaminophen And Codeine 28 in 1 BOTTLE, PLASTIC TABLET 28 4 52959-003-30 Acetaminophen And Codeine 30 in 1 BOTTLE, PLASTIC TABLET 30 4 52959-003-40 Acetaminophen And Codeine 40 in 1 BOTTLE, PLASTIC TABLET 40 4 52959-003-42 Acetaminophen And Codeine 42 in 1 BOTTLE, PLASTIC TABLET 42 4 52959-003-45 Acetaminophen And Codeine 45 in 1 BOTTLE, PLASTIC TABLET 45 4 52959-003-50 Acetaminophen And Codeine 50 in 1 BOTTLE, PLASTIC TABLET 50 4 52959-003-60 Acetaminophen And Codeine 60 in 1 BOTTLE, PLASTIC TABLET 60 4 52959-003-75 Acetaminophen And Codeine 75 in 1 BOTTLE, PLASTIC TABLET 75 4 52959-003-84 Acetaminophen And Codeine 84 in 1 BOTTLE, PLASTIC TABLET 84 4 52959-003-90 Acetaminophen And Codeine 90 in 1 BOTTLE, PLASTIC TABLET 90 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded .GAMMA.-AMINOBUTYRIC ACID ACTIVE INGREDIENT 2ACZ6IPC6I THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 .GAMMA.-AMINOBUTYRIC ACID ACTIVE MOIETY 2ACZ6IPC6I THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 CODEINE ACTIVE MOIETY Q830PW7520 THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 POVIDONE INACTIVE INGREDIENT FZ989GH94E THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 1 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 1 CODEINE ACTIVE MOIETY Q830PW7520 ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 1 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-003 THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] 7 Legacy NDC 20110815_a2ca6210-578d-496c-9a0e-6eb716f87ae6.zip 52959-003 ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.] 4 Legacy NDC, 22 package rows 20180915_97b0ee29-d08e-4d9b-82ed-3ce287dbec28.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-003-00 52959000300 100 in 1 BOTTLE, PLASTIC Historical 52959-003-02 52959000302 120 in 1 BOTTLE, PLASTIC Historical 52959-003-04 52959000304 4 in 1 BOTTLE, PLASTIC Historical 52959-003-06 52959000306 6 in 1 BOTTLE, PLASTIC Historical 52959-003-10 52959000310 10 in 1 BOTTLE, PLASTIC Historical 52959-003-12 52959000312 12 in 1 BOTTLE, PLASTIC Historical 52959-003-14 52959000314 14 in 1 BOTTLE, PLASTIC Historical 52959-003-15 52959000315 15 in 1 BOTTLE, PLASTIC Historical 52959-003-16 52959000316 16 in 1 BOTTLE, PLASTIC Historical 52959-003-20 52959000320 20 in 1 BOTTLE, PLASTIC Historical 52959-003-24 52959000324 24 in 1 BOTTLE, PLASTIC Historical 52959-003-25 52959000325 25 in 1 BOTTLE, PLASTIC Historical 52959-003-28 52959000328 28 in 1 BOTTLE, PLASTIC Historical 52959-003-30 52959000330 30 in 1 BOTTLE Historical 52959-003-40 52959000340 40 in 1 BOTTLE, PLASTIC Historical 52959-003-42 52959000342 42 in 1 BOTTLE, PLASTIC Historical 52959-003-45 52959000345 45 in 1 BOTTLE, PLASTIC Historical 52959-003-50 52959000350 50 in 1 BOTTLE, PLASTIC Historical 52959-003-60 52959000360 60 in 1 BOTTLE, PLASTIC Historical 52959-003-75 52959000375 75 in 1 BOTTLE, PLASTIC Historical 52959-003-84 52959000384 84 in 1 BOTTLE, PLASTIC Historical 52959-003-90 52959000390 90 in 1 BOTTLE, PLASTIC Historical