butalbital, acetaminophen, and caffeine (0591-3369)

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen, and caffeine

Generic Name butalbital, acetaminophen, and caffeine

Labeler actavis pharma, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/1, butalbital 50 mg/1, caffeine 40 mg/1

Manufacturer

Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3369

Product ID 0591-3369_4f43a8e6-42b9-4743-9ffa-3783e1b5e15b

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA088616

Listing Expiration 2027-12-31

Marketing Start 2007-12-13

Pharmacologic Class

Established (EPC)

barbiturate [epc] central nervous system stimulant [epc] methylxanthine [epc]

Chemical Structure

barbiturates [cs] xanthines [cs]

Physiologic Effect

central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05913369

Hyphenated Format 0591-3369

Supplemental Identifiers

RxCUI

238154

UPC

0305913369016

UNII

362O9ITL9D KHS0AZ4JVK 3G6A5W338E

NUI

N0000175693 M0002177 N0000175739 N0000175729 N0000175790 M0023046

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name butalbital, acetaminophen, and caffeine (source: ndc)

Generic Name butalbital, acetaminophen, and caffeine (source: ndc)

Application Number ANDA088616 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
50 mg/1
40 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (0591-3369-01)
500 TABLET in 1 BOTTLE (0591-3369-05)

source: ndc

Packages (2)

0591-3369-01 100 TABLET in 1 BOTTLE (0591-3369-01) 0591-3369-05 500 TABLET in 1 BOTTLE (0591-3369-05)

Ingredients (3)

acetaminophen (325 mg/1) butalbital (50 mg/1) caffeine (40 mg/1)

Linked Drug Pages (1)

Butalbital, Acetaminophen, and Caffeine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "4f43a8e6-42b9-4743-9ffa-3783e1b5e15b", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0305913369016"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238154"], "spl_set_id": ["a6cbc17f-5c60-489c-8029-84b0add556d8"], "pharm_class_cs": ["Barbiturates [CS]", "Xanthines [CS]"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Barbiturate [EPC]", "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0591-3369-01)", "package_ndc": "0591-3369-01", "marketing_start_date": "20071213"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0591-3369-05)", "package_ndc": "0591-3369-05", "marketing_start_date": "20071213"}], "brand_name": "Butalbital, Acetaminophen, and Caffeine", "product_id": "0591-3369_4f43a8e6-42b9-4743-9ffa-3783e1b5e15b", "dosage_form": "TABLET", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "0591-3369", "generic_name": "Butalbital, Acetaminophen, and Caffeine", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital, Acetaminophen, and Caffeine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}, {"name": "CAFFEINE", "strength": "40 mg/1"}], "application_number": "ANDA088616", "marketing_category": "ANDA", "marketing_start_date": "20071213", "listing_expiration_date": "20271231"}