FDA.reportPublic FDA data

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product NDC
70518-4601
Requested package NDC
70518-4601-1
11-digit product format
705184601
Labeler code
70518
Product ID
70518-4601_522ac851-68c8-7564-e063-6394a90a2fa8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214287
Marketing category
ANDA
Marketing start
2026-04-16
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A214287-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-181c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214287-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA2024-01-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214287-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214287-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214287-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214287-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214287-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214287-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214287-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214287-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214287-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214287-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214287-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214287-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214287-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214287-001AA18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214287-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214287-001AA11c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214287-001AA1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTALBITAL325 mg/1
ACETAMINOPHEN50 mg/1
CAFFEINE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KHS0AZ4JVKInternal UNII lookup
362O9ITL9DInternal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238154Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c761587-3090-425e-bc83-139c32c9439dAvailable on FDA.report

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
70518-4601-0BUTALBITAL, ACETAMINOPHEN AND CAFFEINE90 in 1 BOTTLE, PLASTICTABLET904
70518-4601-1BUTALBITAL, ACETAMINOPHEN AND CAFFEINE150 in 1 BOTTLE, PLASTICTABLET1504
70518-4601-2BUTALBITAL, ACETAMINOPHEN AND CAFFEINE120 in 1 BOTTLE, PLASTICTABLET1204

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackf6bd2076-869e-40de-94ce-6be43d50f6802026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEREMEDYREPACK INC.3c761587-3090-425e-bc83-139c32c9439d2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
ndc (package): 70518-4601-1
ndc (product): 70518-4601
ndc11 (package): 70518460101
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAdvanced Rx of Tennessee, LLC45a18fad-ad4e-3a1b-e063-6394a90a23cf2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack2eefa0ac-70f6-43ab-b59e-c4ecad853fe72025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackb9df47cf-f999-49d8-95b9-374c0539b6a12025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEPreferred Pharmaceuticals Inc.91e50642-d278-47c6-944b-4ed907e87e6b2024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGEN PHARMACEUTICALS LLC24813ec6-0111-4782-9182-a2b93501a2bc2024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214287
application number: ANDA214287

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN3c761587-3090-425e-bc83-139c32c9439d4
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD3c761587-3090-425e-bc83-139c32c9439d4
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY3c761587-3090-425e-bc83-139c32c9439d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4601-170518460101150 TABLET in 1 BOTTLE, PLASTIC (70518-4601-1) 150 tablet2026-05-03NoNoCurrent