hydrocodone bitartrate and acetaminophen

Product NDC
46672-147
11-digit product format
466720147
Labeler code
46672
Product ID
46672-147_acaf0ba7-4996-497e-e053-2995a90a1e39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA040432
Marketing category
ANDA
Marketing start
2003-01-20
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
8 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