CARISOPRODOL

Product NDC
68788-9976
11-digit product format
687889976
Labeler code
68788
Product ID
68788-9976_9b36f207-9e52-4a50-a49c-cf2914d2bcb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARISOPRODOL
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA040823
Marketing category
ANDA
Marketing start
2015-05-01
Marketing end
0000-00-00
Substance
CARISOPRODOL
Active strength
350 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9976DDiscontinued by firm2026-08-17
excluded packagepackage68788-997668788-9976-0DDiscontinued by firm2026-08-17
excluded packagepackage68788-997668788-9976-1DDiscontinued by firm2026-08-17
excluded packagepackage68788-997668788-9976-2DDiscontinued by firm2026-08-17
excluded packagepackage68788-997668788-9976-3DDiscontinued by firm2026-08-17
excluded packagepackage68788-997668788-9976-5DDiscontinued by firm2026-08-17
excluded packagepackage68788-997668788-9976-6DDiscontinued by firm2026-08-17
excluded packagepackage68788-997668788-9976-8DDiscontinued by firm2026-08-17
excluded packagepackage68788-997668788-9976-9DDiscontinued by firm2026-08-17

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 2 · 108 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 packagepackage68788-9976-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9976-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9976-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9976-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9976-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9976-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9976-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9976-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9976-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9976-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9976-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9976-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9976-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9976-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9976-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9976-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9976-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9976-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9976-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9976-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9976-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9976-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9976-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9976-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9976-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9976-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9976-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9976-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9976-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9976-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9976-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9976-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9976-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9976-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9976-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9976-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9976-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9976-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9976-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9976-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9976-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9976-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9976-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9976-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9976-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9976-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9976-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9976-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9976-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9976-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9976-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9976-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9976-5302b2466d912…e7b80fea0513…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040823-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA2008-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040823-001AA

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-223f01610625f2…
2019-09-15 20:21 UTC2019-09A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040823-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040823-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040823-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040823-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040823-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040823-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040823-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040823-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040823-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040823-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040823-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040823-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040823-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040823-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040823-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040823-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040823-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040823-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040823-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040823-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040823-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040823-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040823-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040823-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040823-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040823-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040823-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040823-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040823-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040823-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040823-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040823-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040823-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040823-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040823-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040823-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040823-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040823-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040823-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040823-001AA1e64feba35796…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARISOPRODOLACTIVE INGREDIENT21925K482HCARISOPRODOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CARISOPRODOLACTIVE MOIETY21925K482HCARISOPRODOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCARISOPRODOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARISOPRODOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCARISOPRODOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARISOPRODOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARISOPRODOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARISOPRODOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARISOPRODOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARISOPRODOLCARISOPRODOLIngenus Pharmaceuticals, LLC5eff5b4c-c363-45b5-9eef-b724233a51e22023-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040823
application number: ANDA040823