FDA.reportPublic FDA data

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product NDC
71335-2630
11-digit product format
713352630
Labeler code
71335
Product ID
71335-2630_eab10910-f579-4542-a999-4d3eb874d3cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214287
Marketing category
ANDA
Marketing start
2024-05-01
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 AND 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
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2630-0BUTALBITAL, ACETAMINOPHEN AND CAFFEINE84 in 1 BOTTLETABLET841
71335-2630-1BUTALBITAL, ACETAMINOPHEN AND CAFFEINE20 in 1 BOTTLETABLET201
71335-2630-2BUTALBITAL, ACETAMINOPHEN AND CAFFEINE30 in 1 BOTTLETABLET301
71335-2630-3BUTALBITAL, ACETAMINOPHEN AND CAFFEINE60 in 1 BOTTLETABLET601
71335-2630-4BUTALBITAL, ACETAMINOPHEN AND CAFFEINE90 in 1 BOTTLETABLET901
71335-2630-5BUTALBITAL, ACETAMINOPHEN AND CAFFEINE50 in 1 BOTTLETABLET501
71335-2630-6BUTALBITAL, ACETAMINOPHEN AND CAFFEINE6 in 1 BOTTLETABLET61
71335-2630-7BUTALBITAL, ACETAMINOPHEN AND CAFFEINE120 in 1 BOTTLETABLET1201
71335-2630-8BUTALBITAL, ACETAMINOPHEN AND CAFFEINE40 in 1 BOTTLETABLET401
71335-2630-9BUTALBITAL, ACETAMINOPHEN AND CAFFEINE12 in 1 BOTTLETABLET121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2630-3EA - Each71335-26302db6d075-5e68-42a7-b795-19d1ffc1f5f512025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN2eefa0ac-70f6-43ab-b59e-c4ecad853fe71
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD2eefa0ac-70f6-43ab-b59e-c4ecad853fe71
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY2eefa0ac-70f6-43ab-b59e-c4ecad853fe71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2630-07133526300084 TABLET in 1 BOTTLE (71335-2630-0) 84 tablet2025-06-02NoNoHistorical
71335-2630-17133526300120 TABLET in 1 BOTTLE (71335-2630-1) 20 tablet2025-06-02NoNoHistorical
71335-2630-27133526300230 TABLET in 1 BOTTLE (71335-2630-2) 30 tablet2025-06-02NoNoHistorical
71335-2630-37133526300360 TABLET in 1 BOTTLE (71335-2630-3) 60 tablet2025-06-02NoNoHistorical
71335-2630-47133526300490 TABLET in 1 BOTTLE (71335-2630-4) 90 tablet2025-06-02NoNoHistorical
71335-2630-57133526300550 TABLET in 1 BOTTLE (71335-2630-5) 50 tablet2025-06-02NoNoHistorical
71335-2630-6713352630066 TABLET in 1 BOTTLE (71335-2630-6) 6 tablet2025-06-02NoNoHistorical
71335-2630-771335263007120 TABLET in 1 BOTTLE (71335-2630-7) 120 tablet2025-06-02NoNoHistorical
71335-2630-87133526300840 TABLET in 1 BOTTLE (71335-2630-8) 40 tablet2025-06-02NoNoHistorical
71335-2630-97133526300912 TABLET in 1 BOTTLE (71335-2630-9) 12 tablet2025-06-02NoNoHistorical