Acetaminophen and Codeine Phosphate

Product NDC
68071-3272
11-digit product format
680713272
Labeler code
68071
Product ID
68071-3272_4eca42e2-64b0-51ca-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA202800
Marketing category
ANDA
Marketing start
2017-01-05
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record