butalbital, acetaminophen and caffeine

Product NDC
51862-542
11-digit product format
518620542
Labeler code
51862
Product ID
51862-542_ea233792-038e-39e7-e053-2995a90a20ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butalbital, acetaminophen and caffeine
Dosage form
CAPSULE
Route
ORAL
Labeler
Mayne Pharma
Application
ANDA210817
Marketing category
ANDA
Marketing start
2020-03-09
Marketing end
2022-12-31
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
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51862-542DDiscontinued by firm2026-08-03
excluded productproduct51862-542DDiscontinued by firm2026-08-03
excluded packagepackage51862-54251862-542-01DDiscontinued by firm2026-08-03
excluded packagepackage51862-54251862-542-01DDiscontinued 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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51862-542-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51862-542-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51862-542-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51862-542-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51862-542-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51862-542-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51862-542-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51862-542-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51862-542-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51862-542-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51862-542-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51862-542-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51862-542-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51862-542-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51862-542-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51862-542-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51862-542-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51862-542-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51862-542-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51862-542-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51862-542-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51862-542-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51862-542-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51862-542-01557ba5c1ecfa…9c80585c8c6e…

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
A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210817-001AA

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 UTC2026-02A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-174b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210817-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORALAA2019-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210817-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210817-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210817-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210817-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210817-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210817-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210817-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210817-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210817-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210817-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210817-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210817-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210817-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210817-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210817-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210817-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210817-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210817-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210817-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210817-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A210817-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210817-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210817-001AA1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210817-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210817-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210817-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210817-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210817-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210817-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210817-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210817-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210817-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210817-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210817-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210817-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210817-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210817-001AA1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-542-01EA - Each51862-54207d1b083-e3b5-4a54-9db0-68fabfa6ff8a12020-05-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-542-0151862054201100 CAPSULE in 1 BOTTLE, PLASTIC (51862-542-01) 100 capsule2020-03-090000-00-00NoNoCurrent