butalbital, aspirin, caffeine and codeine phosphate

Generic: butalbital, aspirin, caffeine and codeine phosphate

Labeler: amneal pharmaceuticals of new york, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital, aspirin, caffeine and codeine phosphate
Generic Name butalbital, aspirin, caffeine and codeine phosphate
Labeler amneal pharmaceuticals of new york, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

aspirin 325 mg/1, butalbital 50 mg/1, caffeine 40 mg/1, codeine phosphate 30 mg/1

Manufacturer
Amneal Pharmaceuticals of New York, LLC

Identifiers & Regulatory

Product NDC 69238-1993
Product ID 69238-1993_f3869a7a-b5f3-4279-b07b-ff01a8c2a286
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074951
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2019-04-01

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 692381993
Hyphenated Format 69238-1993

Supplemental Identifiers

RxCUI
994237
UPC
0369238199314
UNII
R16CO5Y76E KHS0AZ4JVK 3G6A5W338E GSL05Y1MN6
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, caffeine and codeine phosphate (source: ndc)
Generic Name butalbital, aspirin, caffeine and codeine phosphate (source: ndc)
Application Number ANDA074951 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 50 mg/1
  • 40 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (69238-1993-1)
source: ndc

Packages (1)

69238-1993-1 100 CAPSULE in 1 BOTTLE (69238-1993-1)

Ingredients (4)

aspirin (325 mg/1) butalbital (50 mg/1) caffeine (40 mg/1) codeine phosphate (30 mg/1)

Linked Drug Pages (1)

BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f3869a7a-b5f3-4279-b07b-ff01a8c2a286", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0369238199314"], "unii": ["R16CO5Y76E", "KHS0AZ4JVK", "3G6A5W338E", "GSL05Y1MN6"], "rxcui": ["994237"], "spl_set_id": ["828e30fa-7bb1-486b-80ee-806fce45e4e4"], "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": ["Amneal Pharmaceuticals of New York, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (69238-1993-1)", "package_ndc": "69238-1993-1", "marketing_start_date": "20190401"}], "brand_name": "BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE", "product_id": "69238-1993_f3869a7a-b5f3-4279-b07b-ff01a8c2a286", "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]", "Full Opioid Agonists [MoA]", "Methylxanthine [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Opioid Agonist [EPC]", "Platelet Aggregation Inhibitor [EPC]", "Xanthines [CS]"], "product_ndc": "69238-1993", "dea_schedule": "CIII", "generic_name": "BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE", "labeler_name": "Amneal Pharmaceuticals of New York, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE", "active_ingredients": [{"name": "ASPIRIN", "strength": "325 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}, {"name": "CAFFEINE", "strength": "40 mg/1"}, {"name": "CODEINE PHOSPHATE", "strength": "30 mg/1"}], "application_number": "ANDA074951", "marketing_category": "ANDA", "marketing_start_date": "20190401", "listing_expiration_date": "20271231"}