butalbital, acetaminophen, caffeine (50268-553)

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen, caffeine

Generic Name butalbital, acetaminophen, and caffeine

Labeler avpak

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

AvPAK

Identifiers & Regulatory

Product NDC 50268-553

Product ID 50268-553_2b4a7d93-e919-27be-e063-6294a90a1db0

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209587

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2022-08-11

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 50268553

Hyphenated Format 50268-553

Supplemental Identifiers

RxCUI

238154

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, caffeine (source: ndc)

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

Application Number ANDA209587 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

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

source: ndc

Packaging

30 BLISTER PACK in 1 BOX (50268-553-13) / 1 TABLET in 1 BLISTER PACK (50268-553-11)

source: ndc

Packages (1)

50268-553-13 30 BLISTER PACK in 1 BOX (50268-553-13) / 1 TABLET in 1 BLISTER PACK (50268-553-11)

Ingredients (3)

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

Linked Drug Pages (1)

Butalbital, Acetaminophen, Caffeine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2b4a7d93-e919-27be-e063-6294a90a1db0", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238154"], "spl_set_id": ["e5fbd6b8-85e7-8847-e053-2a95a90a52ed"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX (50268-553-13)  / 1 TABLET in 1 BLISTER PACK (50268-553-11)", "package_ndc": "50268-553-13", "marketing_start_date": "20220811"}], "brand_name": "Butalbital, Acetaminophen, Caffeine", "product_id": "50268-553_2b4a7d93-e919-27be-e063-6294a90a1db0", "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": "50268-553", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen, and Caffeine", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital, Acetaminophen, Caffeine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}, {"name": "CAFFEINE", "strength": "40 mg/1"}], "application_number": "ANDA209587", "marketing_category": "ANDA", "marketing_start_date": "20220811", "listing_expiration_date": "20261231"}