butalbital, acetaminophen, and caffeine (55154-3356)

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen, and caffeine

Generic Name butalbital, acetaminophen, and caffeine

Labeler cardinal health 107, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-3356

Product ID 55154-3356_28e65048-98f8-4305-b99d-8b919a57066b

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA200243

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2012-09-13

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 551543356

Hyphenated Format 55154-3356

Supplemental Identifiers

RxCUI

238154

UPC

0055154335607

UNII

362O9ITL9D KHS0AZ4JVK 3G6A5W338E

NUI

N0000175693 M0002177 N0000175739 N0000175729 N0000175790 M0023046

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 ANDA200243 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

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

source: ndc

Packaging

10 BLISTER PACK in 1 BAG (55154-3356-0) / 1 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

55154-3356-0 10 BLISTER PACK in 1 BAG (55154-3356-0) / 1 TABLET in 1 BLISTER PACK

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": "28e65048-98f8-4305-b99d-8b919a57066b", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0055154335607"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238154"], "spl_set_id": ["ab70f3dc-708e-4455-99ff-a2b9fe2d71a3"], "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": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-3356-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-3356-0", "marketing_start_date": "20120913"}], "brand_name": "Butalbital, Acetaminophen, and Caffeine", "product_id": "55154-3356_28e65048-98f8-4305-b99d-8b919a57066b", "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": "55154-3356", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen, and Caffeine", "labeler_name": "Cardinal Health 107, LLC", "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": "ANDA200243", "marketing_category": "ANDA", "marketing_start_date": "20120913", "listing_expiration_date": "20261231"}