butalbital, aspirin, and caffeine

Generic: butalbital, aspirin, and caffeine

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital, aspirin, and caffeine
Generic Name butalbital, aspirin, and caffeine
Labeler westminster pharmaceuticals, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-416
Product ID 69367-416_ac7dfe8b-b751-4ee0-8f41-5e3f4b934c6f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078149
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2025-10-24

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc] platelet aggregation inhibitor [epc] barbiturate [epc] central nervous system stimulant [epc] methylxanthine [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs] barbiturates [cs] xanthines [cs]
Physiologic Effect
decreased prostaglandin production [pe] decreased platelet aggregation [pe] central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367416
Hyphenated Format 69367-416

Supplemental Identifiers

RxCUI
238134
UPC
0369367416016
UNII
R16CO5Y76E KHS0AZ4JVK 3G6A5W338E
NUI
N0000000160 N0000008836 M0001335 N0000175722 N0000175578 N0000008832 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, aspirin, and caffeine (source: ndc)
Generic Name butalbital, aspirin, and caffeine (source: ndc)
Application Number ANDA078149 (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 (69367-416-01)
source: ndc

Packages (1)

69367-416-01 100 CAPSULE in 1 BOTTLE (69367-416-01)

Ingredients (3)

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

Linked Drug Pages (1)

BUTALBITAL, ASPIRIN, AND CAFFEINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ac7dfe8b-b751-4ee0-8f41-5e3f4b934c6f", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0369367416016"], "unii": ["R16CO5Y76E", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238134"], "spl_set_id": ["ac6ceec2-72d8-4901-9d30-278965a79049"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]", "Barbiturates [CS]", "Xanthines [CS]"], "pharm_class_pe": ["Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]", "Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]", "Barbiturate [EPC]", "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (69367-416-01)", "package_ndc": "69367-416-01", "marketing_start_date": "20251024"}], "brand_name": "BUTALBITAL, ASPIRIN, AND CAFFEINE", "product_id": "69367-416_ac7dfe8b-b751-4ee0-8f41-5e3f4b934c6f", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Barbiturate [EPC]", "Barbiturates [CS]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Platelet Aggregation [PE]", "Decreased Prostaglandin Production [PE]", "Methylxanthine [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]", "Xanthines [CS]"], "product_ndc": "69367-416", "dea_schedule": "CIII", "generic_name": "BUTALBITAL, ASPIRIN, AND CAFFEINE", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUTALBITAL, ASPIRIN, AND CAFFEINE", "active_ingredients": [{"name": "ASPIRIN", "strength": "325 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}, {"name": "CAFFEINE", "strength": "40 mg/1"}], "application_number": "ANDA078149", "marketing_category": "ANDA", "marketing_start_date": "20251024", "listing_expiration_date": "20261231"}