Acetaminophen and Codeine Phosphate

Product NDC
71335-2916
11-digit product format
713352916
Labeler code
71335
Product ID
71335-2916_d4fdfd86-3045-4616-9a46-5ee34a23b507
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089805
Marketing category
ANDA
Marketing start
2024-05-20
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300; 30 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
GSL05Y1MN6CODEINE PHOSPHATE41444-62-6CODEINE PHOSPHATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2916-07133529160040 TABLET in 1 BOTTLE (71335-2916-0) 40 tablet2025-10-28NoNoHistorical
71335-2916-1713352916016 TABLET in 1 BOTTLE (71335-2916-1) 6 tablet2025-10-28NoNoHistorical
71335-2916-27133529160220 TABLET in 1 BOTTLE (71335-2916-2) 20 tablet2025-10-28NoNoHistorical
71335-2916-37133529160330 TABLET in 1 BOTTLE (71335-2916-3) 30 tablet2025-10-28NoNoHistorical
71335-2916-47133529160484 TABLET in 1 BOTTLE (71335-2916-4) 84 tablet2025-10-28NoNoHistorical
71335-2916-57133529160515 TABLET in 1 BOTTLE (71335-2916-5) 15 tablet2025-10-28NoNoHistorical
71335-2916-671335291606120 TABLET in 1 BOTTLE (71335-2916-6) 120 tablet2025-10-28NoNoHistorical
71335-2916-771335291607100 TABLET in 1 BOTTLE (71335-2916-7) 100 tablet2025-10-28NoNoHistorical
71335-2916-87133529160860 TABLET in 1 BOTTLE (71335-2916-8) 60 tablet2025-10-28NoNoHistorical
71335-2916-97133529160990 TABLET in 1 BOTTLE (71335-2916-9) 90 tablet2025-10-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Acetaminophen and Codeine PhosphateBryant Ranch Prepack2025-10-28HUMAN PRESCRIPTION DRUG LABEL1