Butalbital/Acetaminophen/Caffeine

Product NDC

80425-0215

11-digit product format

804250215

Labeler code

80425

Product ID

80425-0215_2a9aa22e-db3d-217b-e063-6294a90a4c41

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Butalbital/Acetaminophen/Caffeine

Dosage form

CAPSULE

Route

ORAL

Labeler

Advanced Rx Pharmacy of Tennessee, LLC

Application

ANDA213321

Marketing category

ANDA

Marketing start

2023-01-03

Substance

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Active strength

300; 50; 40 mg/1; mg/1; mg/1

Pharmacologic classes

Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]

DEA schedule

CIII

NDC exclude flag

No

Listing certified through

2026-12-31

Current FDA listing

Yes