ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
63629-1187
11-digit product format
636291187
Labeler code
63629
Product ID
63629-1187_670a5134-8300-4ee7-a857-1ab0a450d676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211610
Marketing category
ANDA
Marketing start
2020-09-01
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1187-163629118701500 TABLET in 1 BOTTLE (63629-1187-1) 500 tablet2020-09-010000-00-00NoNoCurrent