Butalbital, Acetaminophen and Caffeine

Product NDC

43063-369

11-digit product format

430630369

Labeler code

43063

Product ID

43063-369_639e932c-52ed-d2b3-e053-2a91aa0a1ce9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Butalbital, Acetaminophen and Caffeine

Dosage form

TABLET

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA089718

Marketing category

ANDA

Marketing start

1995-06-12

Marketing end

0000-00-00

Substance

BUTALBITAL; ACETAMINOPHEN; CAFFEINE

Active strength

50 mg/1; mg/1; mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record