Hydrocodone Bitartrate and Acetaminophen

Product NDC
47781-446
11-digit product format
477810446
Labeler code
47781
Product ID
47781-446_189b8dd3-a333-66ad-4bba-8653e163de6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA208540
Marketing category
ANDA
Marketing start
2018-11-08
Marketing end
2021-12-31
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record