ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
60760-581
11-digit product format
607600581
Labeler code
60760
Product ID
60760-581_eac5f2df-119f-1465-e053-2a95a90a03f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA040419
Marketing category
ANDA
Marketing start
2022-09-30
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
60760-581-306076005813030 TABLET in 1 BOTTLE, PLASTIC (60760-581-30) 30 tablet2022-09-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Acetaminophen and Codeine Phosphate Tablets USP CIIIST. MARY'S MEDICAL PARK PHARMACY2022-10-11HUMAN PRESCRIPTION DRUG LABEL1