Hydrocodone Bitartrate and Acetaminophen

Product NDC
71205-660
11-digit product format
712050660
Labeler code
71205
Product ID
71205-660_c6210466-5feb-45d9-b637-b3f482bc3c2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211487
Marketing category
ANDA
Marketing start
2018-11-08
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
71205-660-307120506603030 TABLET in 1 BOTTLE (71205-660-30) 30 tablet2022-05-16NoNoHistorical
71205-660-607120506606060 TABLET in 1 BOTTLE (71205-660-60) 60 tablet2022-05-16NoNoHistorical
71205-660-907120506609090 TABLET in 1 BOTTLE (71205-660-90) 90 tablet2022-05-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydrocodone Bitartrate and Acetaminophen - Proficient Rx LPProficient Rx LP2022-05-01HUMAN PRESCRIPTION DRUG LABEL1