Acetaminophen and Codeine Phosphate

Product NDC
68071-3100
11-digit product format
680713100
Labeler code
68071
Product ID
68071-3100_d775d9ad-438c-17ee-e053-2995a90a38f4
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
2023-12-31
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
68071-3100-26807131000220 TABLET in 1 BOTTLE (68071-3100-2) 20 tablet2017-03-100000-00-00NoNoCurrent
68071-3100-36807131000330 TABLET in 1 BOTTLE (68071-3100-3) 30 tablet2017-03-100000-00-00NoNoCurrent
68071-3100-46807131000424 TABLET in 1 BOTTLE (68071-3100-4) 24 tablet2017-03-100000-00-00NoNoCurrent
68071-3100-56807131000515 TABLET in 1 BOTTLE (68071-3100-5) 15 tablet2017-03-100000-00-00NoNoCurrent
68071-3100-66807131000660 TABLET in 1 BOTTLE (68071-3100-6) 60 tablet2017-03-100000-00-00NoNoCurrent
68071-3100-86807131000884 TABLET in 1 BOTTLE (68071-3100-8) 84 tablet2017-03-100000-00-00NoNoCurrent