butalbital and acetaminophen (70010-054)

Drug Facts

Product Profile

Brand Name butalbital and acetaminophen

Generic Name butalbital and acetaminophen

Labeler granules pharmaceuticals inc.

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

acetaminophen 300 mg/1, butalbital 50 mg/1

Manufacturer

Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-054

Product ID 70010-054_f4a2f8f9-7dc7-395b-e053-2995a90a6f00

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213115

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2020-01-20

Pharmacologic Class

Established (EPC)

barbiturate [epc]

Chemical Structure

barbiturates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70010054

Hyphenated Format 70010-054

Supplemental Identifiers

RxCUI

1995136

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 ANDA213115 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1
50 mg/1

source: ndc

Packaging

100 CAPSULE in 1 BOTTLE (70010-054-01)
500 CAPSULE in 1 BOTTLE (70010-054-05)

source: ndc

Packages (2)

70010-054-01 100 CAPSULE in 1 BOTTLE (70010-054-01) 70010-054-05 500 CAPSULE in 1 BOTTLE (70010-054-05)

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": "f4a2f8f9-7dc7-395b-e053-2995a90a6f00", "openfda": {"nui": ["N0000175693", "M0002177"], "unii": ["362O9ITL9D", "KHS0AZ4JVK"], "rxcui": ["1995136"], "spl_set_id": ["2091c292-b77b-4ce6-8bba-436c74eee3d7"], "pharm_class_cs": ["Barbiturates [CS]"], "pharm_class_epc": ["Barbiturate [EPC]"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70010-054-01)", "package_ndc": "70010-054-01", "marketing_start_date": "20200120"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (70010-054-05)", "package_ndc": "70010-054-05", "marketing_start_date": "20200120"}], "brand_name": "butalbital and acetaminophen", "product_id": "70010-054_f4a2f8f9-7dc7-395b-e053-2995a90a6f00", "dosage_form": "CAPSULE", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]"], "product_ndc": "70010-054", "dea_schedule": "CIII", "generic_name": "butalbital and acetaminophen", "labeler_name": "Granules Pharmaceuticals 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": "ANDA213115", "marketing_category": "ANDA", "marketing_start_date": "20200120", "listing_expiration_date": "20261231"}