butalbital, acetaminophen and caffeine

Generic: butalbital, acetaminophen and caffeine

Labeler: dr. reddy's labratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital, acetaminophen and caffeine
Generic Name butalbital, acetaminophen and caffeine
Labeler dr. reddy's labratories inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, butalbital 50 mg/1, caffeine 40 mg/1

Manufacturer
Dr. Reddy's Labratories Inc.

Identifiers & Regulatory

Product NDC 75907-009
Product ID 75907-009_58adfbf6-a763-1d3a-5be2-f669c7d28129
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089007
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2024-09-01

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 75907009
Hyphenated Format 75907-009

Supplemental Identifiers

RxCUI
238153
UNII
362O9ITL9D KHS0AZ4JVK 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 and caffeine (source: ndc)
Generic Name butalbital, acetaminophen and caffeine (source: ndc)
Application Number ANDA089007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 50 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (75907-009-01)
source: ndc

Packages (1)

75907-009-01 100 CAPSULE in 1 BOTTLE, PLASTIC (75907-009-01)

Ingredients (3)

acetaminophen (325 mg/1) butalbital (50 mg/1) caffeine (40 mg/1)

Linked Drug Pages (1)

butalbital, acetaminophen and caffeine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "58adfbf6-a763-1d3a-5be2-f669c7d28129", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238153"], "spl_set_id": ["69df02fa-c842-48dc-7ac6-5967b7dc30de"], "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": ["Dr. Reddy's Labratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (75907-009-01)", "package_ndc": "75907-009-01", "marketing_start_date": "20240901"}], "brand_name": "butalbital, acetaminophen and caffeine", "product_id": "75907-009_58adfbf6-a763-1d3a-5be2-f669c7d28129", "dosage_form": "CAPSULE", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "75907-009", "dea_schedule": "CIII", "generic_name": "butalbital, acetaminophen and caffeine", "labeler_name": "Dr. Reddy's Labratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "butalbital, acetaminophen and caffeine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}, {"name": "CAFFEINE", "strength": "40 mg/1"}], "application_number": "ANDA089007", "marketing_category": "ANDA", "marketing_start_date": "20240901", "listing_expiration_date": "20261231"}