Acetaminophen and Codeine Phosphate

Product NDC
68071-5025
11-digit product format
680715025
Labeler code
68071
Product ID
68071-5025_bb04a79f-e8c3-63e9-e053-2995a90a0f98
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
2013-04-15
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5025-6680715025066 TABLET in 1 BOTTLE (68071-5025-6) 6 tablet2019-08-140000-00-00NoNoCurrent