butalbital, acetaminophen and caffeine (0527-4094)

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen and caffeine

Generic Name butalbital, acetaminophen and caffeine

Labeler lannett company, inc.

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

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

Manufacturer

Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-4094

Product ID 0527-4094_e505b8df-b401-4967-b4d5-c0717a6a1d08

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212083

Listing Expiration 2026-12-31

Marketing Start 2019-12-17

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 05274094

Hyphenated Format 0527-4094

Supplemental Identifiers

RxCUI

238153

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 ANDA212083 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

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

source: ndc

Packaging

100 CAPSULE in 1 BOTTLE, PLASTIC (0527-4094-37)

source: ndc

Packages (1)

0527-4094-37 100 CAPSULE in 1 BOTTLE, PLASTIC (0527-4094-37)

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": "e505b8df-b401-4967-b4d5-c0717a6a1d08", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238153"], "spl_set_id": ["c1107153-494b-4068-8500-96bc241187a5"], "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": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (0527-4094-37)", "package_ndc": "0527-4094-37", "marketing_start_date": "20191217"}], "brand_name": "butalbital, acetaminophen and caffeine", "product_id": "0527-4094_e505b8df-b401-4967-b4d5-c0717a6a1d08", "dosage_form": "CAPSULE", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "0527-4094", "generic_name": "butalbital, acetaminophen and caffeine", "labeler_name": "Lannett Company, 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": "ANDA212083", "marketing_category": "ANDA", "marketing_start_date": "20191217", "listing_expiration_date": "20261231"}