butalbital, acetaminophen and caffeine

Generic: butalbital, acetaminophen, and caffeine

Labeler: strides pharma science limited
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 strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-157
Product ID 64380-157_808bd69d-2bd5-482b-83d7-f69b222170d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040511
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2022-04-04

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 64380157
Hyphenated Format 64380-157

Supplemental Identifiers

RxCUI
238154
UPC
0364380157014 0364380157021
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 ANDA040511 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 50 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (64380-157-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (64380-157-02)
source: ndc

Packages (2)

64380-157-01 100 TABLET in 1 BOTTLE, PLASTIC (64380-157-01) 64380-157-02 500 TABLET in 1 BOTTLE, PLASTIC (64380-157-02)

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": "808bd69d-2bd5-482b-83d7-f69b222170d8", "openfda": {"nui": ["N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0364380157014", "0364380157021"], "unii": ["362O9ITL9D", "KHS0AZ4JVK", "3G6A5W338E"], "rxcui": ["238154"], "spl_set_id": ["ac9e0cbf-aca6-4cb6-b63a-c25713c5200d"], "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": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (64380-157-01)", "package_ndc": "64380-157-01", "marketing_start_date": "20220404"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (64380-157-02)", "package_ndc": "64380-157-02", "marketing_start_date": "20220404"}], "brand_name": "Butalbital, Acetaminophen and Caffeine", "product_id": "64380-157_808bd69d-2bd5-482b-83d7-f69b222170d8", "dosage_form": "TABLET", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "64380-157", "dea_schedule": "CIII", "generic_name": "Butalbital, Acetaminophen, and Caffeine", "labeler_name": "Strides Pharma Science Limited", "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": "ANDA040511", "marketing_category": "ANDA", "marketing_start_date": "20220404", "listing_expiration_date": "20271231"}