butalbital, acetaminophen, caffeine, and codeine phosphate

Generic: butalbital, acetaminophen, caffeine, and codeine phosphate

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen, caffeine, and codeine phosphate
Generic Name butalbital, acetaminophen, caffeine, and codeine phosphate
Labeler actavis pharma, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3220
Product ID 0591-3220_519e2ce9-e4af-4bd7-96fd-8bee4e3b4537
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020232
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2003-09-18

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 05913220
Hyphenated Format 0591-3220

Supplemental Identifiers

RxCUI
993943
UNII
362O9ITL9D KHS0AZ4JVK 3G6A5W338E GSL05Y1MN6
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, caffeine, and codeine phosphate (source: ndc)
Generic Name butalbital, acetaminophen, caffeine, and codeine phosphate (source: ndc)
Application Number NDA020232 (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 (0591-3220-01)
source: ndc

Packages (1)

0591-3220-01 100 CAPSULE in 1 BOTTLE (0591-3220-01)

Ingredients (4)

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

Linked Drug Pages (1)

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "519e2ce9-e4af-4bd7-96fd-8bee4e3b4537", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E", "GSL05Y1MN6"], "rxcui": ["993943"], "spl_set_id": ["a58819b8-a52c-44a7-9ab0-c74480d98506"], "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": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0591-3220-01)", "package_ndc": "0591-3220-01", "marketing_start_date": "20030918"}], "brand_name": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate", "product_id": "0591-3220_519e2ce9-e4af-4bd7-96fd-8bee4e3b4537", "dosage_form": "CAPSULE", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Full Opioid Agonists [MoA]", "Methylxanthine [EPC]", "Opioid Agonist [EPC]", "Xanthines [CS]"], "product_ndc": "0591-3220", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate", "active_ingredients": [{"name": "ACETAMINOPHEN", "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": "NDA020232", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20030918", "listing_expiration_date": "20271231"}