butalbital, acetaminophen, and caffeine (0527-4095)

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen, and caffeine

Generic Name butalbital, acetaminophen, and caffeine capsules

Labeler lannett company, inc.

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

acetaminophen 300 mg/1, butalbital 50 mg/1, caffeine 40 mg/1

Manufacturer

Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-4095

Product ID 0527-4095_146b5639-6699-471c-ae28-1f576bbead9f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212082

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 05274095

Hyphenated Format 0527-4095

Supplemental Identifiers

RxCUI

889520

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 capsules (source: ndc)

Application Number ANDA212082 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

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

source: ndc

Packaging

100 CAPSULE in 1 BOTTLE (0527-4095-37)

source: ndc

Packages (1)

0527-4095-37 100 CAPSULE in 1 BOTTLE (0527-4095-37)

Ingredients (3)

acetaminophen (300 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": "146b5639-6699-471c-ae28-1f576bbead9f", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["889520"], "spl_set_id": ["4d62259d-a582-4621-b62e-3d5640cadf7c"], "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 (0527-4095-37)", "package_ndc": "0527-4095-37", "marketing_start_date": "20191217"}], "brand_name": "Butalbital, Acetaminophen, and Caffeine", "product_id": "0527-4095_146b5639-6699-471c-ae28-1f576bbead9f", "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": "0527-4095", "generic_name": "Butalbital, Acetaminophen, and Caffeine Capsules", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital, Acetaminophen, and Caffeine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}, {"name": "CAFFEINE", "strength": "40 mg/1"}], "application_number": "ANDA212082", "marketing_category": "ANDA", "marketing_start_date": "20191217", "listing_expiration_date": "20261231"}