Hydrocodone Bitartrate and Acetaminophen

Product NDC
42291-332
11-digit product format
422910332
Labeler code
42291
Product ID
42291-332_9c5d4741-9b7d-33df-e053-2a95a90a6a9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE, Inc.
Application
ANDA040736
Marketing category
ANDA
Marketing start
2016-09-06
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record