butalbital, acetaminophen, caffeine and codeine phosphate

Generic: butalbital, acetaminophen, caffeine and codeine phosphate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

acetaminophen 300 mg/1, butalbital 50 mg/1, caffeine 40 mg/1, codeine phosphate 30 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0650
Product ID 0054-0650_488a9b31-b527-4be6-bc98-04e24a155780
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215138
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2022-05-09

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 00540650
Hyphenated Format 0054-0650

Supplemental Identifiers

RxCUI
993943 1431286
UPC
0300540650254 0300543000018
UNII
KHS0AZ4JVK 362O9ITL9D GSL05Y1MN6 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, caffeine and codeine phosphate (source: ndc)
Generic Name butalbital, acetaminophen, caffeine and codeine phosphate (source: ndc)
Application Number ANDA215138 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 50 mg/1
  • 40 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0054-0650-25)
source: ndc

Packages (1)

0054-0650-25 100 CAPSULE in 1 BOTTLE (0054-0650-25)

Ingredients (4)

acetaminophen (300 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": "488a9b31-b527-4be6-bc98-04e24a155780", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0300540650254", "0300543000018"], "unii": ["KHS0AZ4JVK", "362O9ITL9D", "GSL05Y1MN6", "3G6A5W338E"], "rxcui": ["993943", "1431286"], "spl_set_id": ["6e0e8abc-512b-42f7-8323-434c589edecf"], "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": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0054-0650-25)", "package_ndc": "0054-0650-25", "marketing_start_date": "20220509"}], "brand_name": "Butalbital, Acetaminophen, Caffeine and Codeine Phosphate", "product_id": "0054-0650_488a9b31-b527-4be6-bc98-04e24a155780", "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": "0054-0650", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen, Caffeine and Codeine Phosphate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital, Acetaminophen, Caffeine and Codeine Phosphate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}, {"name": "CAFFEINE", "strength": "40 mg/1"}, {"name": "CODEINE PHOSPHATE", "strength": "30 mg/1"}], "application_number": "ANDA215138", "marketing_category": "ANDA", "marketing_start_date": "20220509", "listing_expiration_date": "20261231"}