FDA.reportPublic FDA data

Butalbital, Acetaminophen and Caffeine

Product NDC
70010-044
11-digit product format
700100044
Labeler code
70010
Product ID
70010-044_0bbc89b6-8700-134d-e063-6394a90a94f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen and Caffeine
Dosage form
CAPSULE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA213321
Marketing category
ANDA
Marketing start
2020-05-05
Substance
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength
300; 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]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213321-001AA

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 UTC2026-02A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213321-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2020-04-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213321-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213321-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213321-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213321-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213321-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213321-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213321-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213321-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213321-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213321-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213321-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213321-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213321-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213321-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213321-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213321-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213321-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213321-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213321-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213321-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A213321-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213321-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213321-001AA1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213321-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213321-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213321-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213321-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213321-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213321-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213321-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213321-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213321-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213321-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213321-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213321-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213321-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213321-001AA1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTALBITAL300 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
889520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2407efce-b77e-4072-bc4b-62c789d01e1aAvailable 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
70010-044-01Butalbital, Acetaminophen and Caffeine100 in 1 BOTTLECAPSULE1006
70010-044-05Butalbital, Acetaminophen and Caffeine500 in 1 BOTTLECAPSULE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-044-01EA - Each70010-044f7e3c18d-6ce4-4d16-817d-26acb4eeb84912020-08-06
70010-044-05EA - Each70010-04495a201fe-8625-4af4-bd05-dd043d62b7e312023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-044BUTALBITA,ACETAMINOPHEN AND CAFFEINE CAPSULE [GRANULES PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20230209_2407efce-b77e-4072-bc4b-62c789d01e1a.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butalbital/Acetaminophen/CaffeineBUTALBITAL/ACETAMINOPHEN/CAFFEINEAdvanced Rx Pharmacy of Tennessee, LLCf16429e2-4944-5bbc-e053-2a95a90ab5282024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213321
application number: ANDA213321
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGranules Pharmaceuticals Inc.2407efce-b77e-4072-bc4b-62c789d01e1a2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213321
application number: ANDA213321
ndc (product): 70010-044

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
889520butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral CapsulePSN2407efce-b77e-4072-bc4b-62c789d01e1a6
889520acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral CapsuleSCD2407efce-b77e-4072-bc4b-62c789d01e1a6
889520APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral CapsuleSY2407efce-b77e-4072-bc4b-62c789d01e1a6
889520butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral CapsulePSNf16429e2-4944-5bbc-e053-2a95a90ab5283
889520acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral CapsuleSCDf16429e2-4944-5bbc-e053-2a95a90ab5283
889520APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral CapsuleSYf16429e2-4944-5bbc-e053-2a95a90ab5283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-044-0170010004401100 CAPSULE in 1 BOTTLE (70010-044-01) 100 capsule2020-05-050000-00-00NoNoCurrent
70010-044-0570010004405500 CAPSULE in 1 BOTTLE (70010-044-05) 500 capsule2020-05-05NoNoCurrent