FDA.reportPublic FDA data

Butalbital, Acetaminophen, Caffeine

Product NDC
76420-802
11-digit product format
764200802
Labeler code
76420
Product ID
76420-802_44818491-48a2-ba4d-e063-6394a90a65f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA209587
Marketing category
ANDA
Marketing start
2019-03-05
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Butalbital, Acetaminophen, Caffeine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
BUTALBITAL50 mg/1
CAFFEINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E
Rxcui238154

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-802-01Butalbital, Acetaminophen, Caffeine100 in 1 BOTTLETABLET1002
76420-802-05Butalbital, Acetaminophen, Caffeine500 in 1 BOTTLETABLET5002
76420-802-10Butalbital, Acetaminophen, Caffeine10 in 1 BOTTLETABLET102
76420-802-12Butalbital, Acetaminophen, Caffeine12 in 1 BOTTLETABLET122
76420-802-20Butalbital, Acetaminophen, Caffeine20 in 1 BOTTLETABLET202
76420-802-30Butalbital, Acetaminophen, Caffeine30 in 1 BOTTLETABLET302
76420-802-60Butalbital, Acetaminophen, Caffeine60 in 1 BOTTLETABLET602
76420-802-90Butalbital, Acetaminophen, Caffeine90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-802-01EA - Each76420-80219a3f51c-4fd9-4f7f-b5c8-b3f0bf0039d212025-12-16
76420-802-05EA - Each76420-80237462468-dbf6-4a1d-94fa-7e952182519212025-12-16
76420-802-10EA - Each76420-802dd53d13d-ffa4-44f9-8c1a-9f5de8a9525412025-12-16
76420-802-12EA - Each76420-80263b6532e-7877-4d99-ae67-dc02204aaf3412025-12-16
76420-802-20EA - Each76420-802809e6648-2a39-425c-98f0-539d7415151412025-12-16
76420-802-30EA - Each76420-8029589fedb-5c45-4d7a-838d-54f38dd3b8f912025-12-16
76420-802-60EA - Each76420-8021573ce29-dffb-4b5e-b193-65f2f9f7805212025-12-16
76420-802-90EA - Each76420-8020504bae8-3296-4a36-8389-472a7cf59ea312025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-802BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [ASCLEMED USA, INC.]1Current NDC, 8 package rows20240503_cce09e09-158f-4927-8a3e-4ec9334f0b7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNcce09e09-158f-4927-8a3e-4ec9334f0b7a2
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDcce09e09-158f-4927-8a3e-4ec9334f0b7a2
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYcce09e09-158f-4927-8a3e-4ec9334f0b7a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-802-0176420080201100 TABLET in 1 BOTTLE (76420-802-01) 100 tablet2024-04-29NoNoHistorical
76420-802-0576420080205500 TABLET in 1 BOTTLE (76420-802-05) 500 tablet2024-04-29NoNoHistorical
76420-802-107642008021010 TABLET in 1 BOTTLE (76420-802-10) 10 tablet2024-04-29NoNoHistorical
76420-802-127642008021212 TABLET in 1 BOTTLE (76420-802-12) 12 tablet2024-04-29NoNoHistorical
76420-802-207642008022020 TABLET in 1 BOTTLE (76420-802-20) 20 tablet2024-04-29NoNoHistorical
76420-802-307642008023030 TABLET in 1 BOTTLE (76420-802-30) 30 tablet2024-04-29NoNoHistorical
76420-802-607642008026060 TABLET in 1 BOTTLE (76420-802-60) 60 tablet2024-04-29NoNoHistorical
76420-802-907642008029090 TABLET in 1 BOTTLE (76420-802-90) 90 tablet2024-04-29NoNoHistorical