Acetaminophen and Codeine Phosphate

Product NDC
71335-2818
11-digit product format
713352818
Labeler code
71335
Product ID
71335-2818_70a10448-acec-42b8-a628-7bd4f3837b20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089828
Marketing category
ANDA
Marketing start
2024-05-20
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300; 60 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
71335-2818-071335281800100 TABLET in 1 BOTTLE (71335-2818-0) 100 tablet2025-10-22NoNoHistorical
71335-2818-17133528180130 TABLET in 1 BOTTLE (71335-2818-1) 30 tablet2025-10-22NoNoHistorical
71335-2818-271335281802120 TABLET in 1 BOTTLE (71335-2818-2) 120 tablet2025-10-22NoNoHistorical
71335-2818-37133528180360 TABLET in 1 BOTTLE (71335-2818-3) 60 tablet2025-10-22NoNoHistorical
71335-2818-47133528180490 TABLET in 1 BOTTLE (71335-2818-4) 90 tablet2025-10-22NoNoHistorical
71335-2818-57133528180540 TABLET in 1 BOTTLE (71335-2818-5) 40 tablet2025-10-22NoNoHistorical
71335-2818-67133528180620 TABLET in 1 BOTTLE (71335-2818-6) 20 tablet2025-10-22NoNoHistorical
71335-2818-771335281807112 TABLET in 1 BOTTLE (71335-2818-7) 112 tablet2025-10-22NoNoHistorical
71335-2818-87133528180884 TABLET in 1 BOTTLE (71335-2818-8) 84 tablet2025-10-22NoNoHistorical
71335-2818-97133528180915 TABLET in 1 BOTTLE (71335-2818-9) 15 tablet2025-10-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Acetaminophen and Codeine PhosphateBryant Ranch Prepack2025-10-22HUMAN PRESCRIPTION DRUG LABEL1