ascomp with codeine

Generic: butalbital, aspirin, cafeine, and codeine phosphate

Labeler: lgm pharma solutions, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ascomp with codeine
Generic Name butalbital, aspirin, cafeine, and codeine phosphate
Labeler lgm pharma solutions, 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
LGM PHARMA SOLUTIONS, LLC

Identifiers & Regulatory

Product NDC 79739-6094
Product ID 79739-6094_8e0b0c51-eba5-42d6-99d3-7623753e3985
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075231
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2001-11-30

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 797396094
Hyphenated Format 79739-6094

Supplemental Identifiers

RxCUI
994237 994239
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 ascomp with codeine (source: ndc)
Generic Name butalbital, aspirin, cafeine, and codeine phosphate (source: ndc)
Application Number ANDA075231 (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 (79739-6094-1)
source: ndc

Packages (1)

Ingredients (4)

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

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "8e0b0c51-eba5-42d6-99d3-7623753e3985", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["R16CO5Y76E", "KHS0AZ4JVK", "3G6A5W338E", "GSL05Y1MN6"], "rxcui": ["994237", "994239"], "spl_set_id": ["1cab3106-1064-4b42-892b-39f405d9e02f"], "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": ["LGM PHARMA SOLUTIONS, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (79739-6094-1)", "package_ndc": "79739-6094-1", "marketing_start_date": "20200724"}], "brand_name": "Ascomp with Codeine", "product_id": "79739-6094_8e0b0c51-eba5-42d6-99d3-7623753e3985", "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": "79739-6094", "dea_schedule": "CIII", "generic_name": "Butalbital, Aspirin, Cafeine, and Codeine Phosphate", "labeler_name": "LGM PHARMA SOLUTIONS, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ascomp with Codeine", "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": "ANDA075231", "marketing_category": "ANDA", "marketing_start_date": "20011130", "listing_expiration_date": "20271231"}