butalbital, acetaminophen and caffeine (13925-536)

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen and caffeine

Generic Name butalbital, acetaminophen and caffeine

Labeler seton pharmaceuticals llc

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

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

Manufacturer

Seton Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 13925-536

Product ID 13925-536_5b7dfab1-0311-4748-9dc0-9e7e33c3eac4

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214087

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2022-03-02

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 13925536

Hyphenated Format 13925-536

Supplemental Identifiers

RxCUI

238153 889520

UPC

0313925535015

UNII

KHS0AZ4JVK 362O9ITL9D 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 ANDA214087 (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 (13925-536-01)

source: ndc

Packages (1)

13925-536-01 100 CAPSULE in 1 BOTTLE (13925-536-01)

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": "5b7dfab1-0311-4748-9dc0-9e7e33c3eac4", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0313925535015"], "unii": ["KHS0AZ4JVK", "362O9ITL9D", "3G6A5W338E"], "rxcui": ["238153", "889520"], "spl_set_id": ["3c5cefe3-c84e-4380-97f3-78e3fe92543a"], "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": ["Seton Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (13925-536-01)", "package_ndc": "13925-536-01", "marketing_start_date": "20220302"}], "brand_name": "BUTALBITAL, ACETAMINOPHEN AND CAFFEINE", "product_id": "13925-536_5b7dfab1-0311-4748-9dc0-9e7e33c3eac4", "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": "13925-536", "dea_schedule": "CIII", "generic_name": "butalbital, acetaminophen and caffeine", "labeler_name": "Seton Pharmaceuticals 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": "ANDA214087", "marketing_category": "ANDA", "marketing_start_date": "20220302", "listing_expiration_date": "20261231"}