FDA.reportPublic FDA data

Butalbital, Acetaminophen and Caffeine

Product NDC
42195-955
Requested package NDC
42195-955-10
11-digit product format
421950955
Labeler code
42195
Product ID
42195-955_ec7c3ac0-9be8-4f4b-8ca8-2790eaaec326
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen and Caffeine
Dosage form
CAPSULE
Route
ORAL
Labeler
Xspire Pharma, LLC
Application
ANDA206615
Marketing category
ANDA
Marketing start
2017-08-04
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength
300 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42195-95542195-955-10DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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
A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-04

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-043f01610625f2…
2019-09-15 20:21 UTC2019-09A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2017-08-04cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A206615-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206615-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206615-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206615-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206615-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206615-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206615-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206615-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A206615-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206615-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206615-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206615-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A206615-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206615-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206615-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206615-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206615-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206615-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206615-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206615-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206615-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206615-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206615-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206615-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206615-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206615-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206615-001AA1cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42195-955-102025-11-11C16284748780-11030e365-17ac-111a-e063-dadaa90a10e2Butalbital, Acetaminophen, and Caffeine Capsules 50 mg / 300 mg / 40 mg
42195-955-102024-01-30C16284748780-11030e365-17ac-111a-e063-dadaa90a10e2Butalbital, Acetaminophen, and Caffeine Capsules 50 mg / 300 mg / 40 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42195-955-10EA - Each42195-9558f6793fc-e4e0-4166-878d-600736a8a66112017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42195-955BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [XSPIRE PHARMA, LLC]11Legacy NDC20220119_56d6c70e-b2c0-0276-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42195-955-1042195095510100 CAPSULE in 1 BOTTLE (42195-955-10) 100 capsule2017-08-040000-00-00NoNoCurrent