Acetaminophen and Codeine Phosphate

Product NDC
63629-7668
11-digit product format
636297668
Labeler code
63629
Product ID
63629-7668_15c84a88-27ea-4111-a88f-731691d7b9e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2021-12-31
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
63629-7668-16362976680120 TABLET in 1 BOTTLE (63629-7668-1) 20 tablet2016-05-230000-00-00NoNoCurrent
63629-7668-26362976680215 TABLET in 1 BOTTLE (63629-7668-2) 15 tablet2016-05-230000-00-00NoNoCurrent