butalbital and acetaminophen

Generic: butalbital and acetaminophen

Labeler: aarkish pharmaceuticals nj inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital and acetaminophen
Generic Name butalbital and acetaminophen
Labeler aarkish pharmaceuticals nj inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, butalbital 50 mg/1

Manufacturer
Aarkish Pharmaceuticals NJ Inc.

Identifiers & Regulatory

Product NDC 81005-123
Product ID 81005-123_37ca06ac-1f37-4952-e063-6394a90a2a0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214955
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2024-12-03

Pharmacologic Class

Established (EPC)
barbiturate [epc]
Chemical Structure
barbiturates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81005123
Hyphenated Format 81005-123

Supplemental Identifiers

RxCUI
1249617
UNII
362O9ITL9D KHS0AZ4JVK
NUI
N0000175693 M0002177

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 and acetaminophen (source: ndc)
Generic Name butalbital and acetaminophen (source: ndc)
Application Number ANDA214955 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (81005-123-01)
source: ndc

Packages (1)

81005-123-01 100 TABLET in 1 BOTTLE (81005-123-01)

Ingredients (2)

acetaminophen (300 mg/1) butalbital (50 mg/1)

Linked Drug Pages (1)

BUTALBITAL AND ACETAMINOPHEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37ca06ac-1f37-4952-e063-6394a90a2a0e", "openfda": {"nui": ["N0000175693", "M0002177"], "unii": ["362O9ITL9D", "KHS0AZ4JVK"], "rxcui": ["1249617"], "spl_set_id": ["82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a6"], "pharm_class_cs": ["Barbiturates [CS]"], "pharm_class_epc": ["Barbiturate [EPC]"], "manufacturer_name": ["Aarkish Pharmaceuticals NJ Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (81005-123-01)", "package_ndc": "81005-123-01", "marketing_start_date": "20241203"}], "brand_name": "BUTALBITAL AND ACETAMINOPHEN", "product_id": "81005-123_37ca06ac-1f37-4952-e063-6394a90a2a0e", "dosage_form": "TABLET", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]"], "product_ndc": "81005-123", "dea_schedule": "CIII", "generic_name": "butalbital and acetaminophen", "labeler_name": "Aarkish Pharmaceuticals NJ Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUTALBITAL AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}], "application_number": "ANDA214955", "marketing_category": "ANDA", "marketing_start_date": "20241203", "listing_expiration_date": "20261231"}