HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
60760-870
11-digit product format
607600870
Labeler code
60760
Product ID
60760-870_3d329316-3129-84e2-e063-6394a90a46d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA040409
Marketing category
ANDA
Marketing start
2000-10-20
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
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
NO70W886KKHYDROCODONE BITARTRATE34195-34-1HYDROCODONE BITARTRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-870-306076008703030 TABLET in 1 BOTTLE, PLASTIC (60760-870-30) 30 tablet2025-08-22NoNoHistorical
60760-870-606076008706060 TABLET in 1 BOTTLE, PLASTIC (60760-870-60) 60 tablet2025-08-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HYDROCODONE BITARTRATE AND ACETAMINOPHENST. MARY'S MEDICAL PARK PHARMACY2025-08-25HUMAN PRESCRIPTION DRUG LABEL1