Home NDC 64380-157 Butalbital, Acetaminophen and Caffeine
Product NDC 64380-157
11-digit product format 643800157
Labeler code 64380
Product ID 64380-157_808bd69d-2bd5-482b-83d7-f69b222170d8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, and Caffeine
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA040511
Marketing category ANDA
Marketing start 2022-04-04
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 325; 50; 40 mg/1; mg/1; mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Butalbital, Acetaminophen and Caffeine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E Rxcui 238154
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 64380-157-01 2024-04-22 C162847 48780-1 1030e365-30c8-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP CIII 50 mg/325 mg/40 mg 64380-157-01 2024-04-22 C162847 48780-1 1030e365-30c8-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP CIII 50 mg/325 mg/40 mg 64380-157-02 2024-04-22 C162847 48780-1 1030e365-30c8-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP CIII 50 mg/325 mg/40 mg 64380-157-02 2024-04-22 C162847 48780-1 1030e365-30c8-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP CIII 50 mg/325 mg/40 mg 64380-157-01 2024-01-30 C162847 48780-1 1030e365-30c8-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP CIII 50 mg/325 mg/40 mg 64380-157-01 2024-01-30 C162847 48780-1 1030e365-30c8-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP CIII 50 mg/325 mg/40 mg 64380-157-02 2024-01-30 C162847 48780-1 1030e365-30c8-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP CIII 50 mg/325 mg/40 mg 64380-157-02 2024-01-30 C162847 48780-1 1030e365-30c8-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP CIII 50 mg/325 mg/40 mg
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-157-01 Butalbital, Acetaminophen and Caffeine 100 in 1 BOTTLE, PLASTIC TABLET 100 6 64380-157-02 Butalbital, Acetaminophen and Caffeine 500 in 1 BOTTLE, PLASTIC TABLET 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-157 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [STRIDES PHARMA SCIENCE LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20240423_ac9e0cbf-aca6-4cb6-b63a-c25713c5200d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64380-157-01 64380015701 100 TABLET in 1 BOTTLE, PLASTIC (64380-157-01) 100 tablet 2022-04-04 0000-00-00 No No Current 64380-157-02 64380015702 500 TABLET in 1 BOTTLE, PLASTIC (64380-157-02) 500 tablet 2022-04-04 0000-00-00 No No Current