Acetaminophen and Codeine Phosphate

Product NDC
68788-0285
11-digit product format
687880285
Labeler code
68788
Product ID
68788-0285_1fe4347d-8a47-4ec5-86a7-d10d82576e0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA088628
Marketing category
ANDA
Marketing start
2011-03-17
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