Hydrocodone Bitartrate and Acetaminophen

Product NDC
60687-418
11-digit product format
606870418
Labeler code
60687
Product ID
60687-418_2b5f781e-1360-0d65-e063-6294a90aa682
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA210211
Marketing category
ANDA
Marketing start
2019-04-15
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 10 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
60687-418-0160687041801100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-418-01) / 1 TABLET in 1 BLISTER PACK (60687-418-11) 100 blister pack2019-04-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII 8439601/1124 Rx onlyAmerican Health Packaging2025-01-10HUMAN PRESCRIPTION DRUG LABEL8