ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
63629-5666
11-digit product format
636295666
Labeler code
63629
Product ID
63629-5666_e40aa43d-1388-4e0c-8d3d-6420c86feab4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040419
Marketing category
ANDA
Marketing start
2001-05-31
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
63629-5666-16362956660110 TABLET in 1 BOTTLE (63629-5666-1) 10 tablet2025-06-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Acetaminophen and Codeine Phosphate Tablets USP CIIIBryant Ranch Prepack2025-06-05HUMAN PRESCRIPTION DRUG LABEL1