Acetaminophen and Codeine Phosphate

Product NDC
68071-3061
11-digit product format
680713061
Labeler code
68071
Product ID
68071-3061_bb049c3f-44a0-4146-e053-2a95a90a7b73
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
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
68071-3061-26807130610212 TABLET in 1 BOTTLE (68071-3061-2) 12 tablet2017-03-140000-00-00NoNoCurrent
68071-3061-4680713061044 TABLET in 1 BOTTLE (68071-3061-4) 4 tablet2017-03-140000-00-00NoNoCurrent
68071-3061-6680713061066 TABLET in 1 BOTTLE (68071-3061-6) 6 tablet2017-03-140000-00-00NoNoCurrent