Carisoprodol

Product NDC
67296-0271
11-digit product format
672960271
Labeler code
67296
Product ID
67296-0271_15a13d7b-63f9-4c78-9ca8-2416bf41d70a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA040245
Marketing category
ANDA
Marketing start
1997-09-08
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
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-0271IInactivated by FDA2026-08-17
excluded packagepackage67296-027167296-0271-1IInactivated by FDA2026-08-17

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 1 · 44 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 packagepackage67296-0271-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-0271-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-0271-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-0271-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-0271-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-0271-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-0271-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-0271-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-0271-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-0271-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-0271-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0271-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0271-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0271-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0271-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-0271-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67296-0271-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67296-0271-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67296-0271-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67296-0271-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67296-0271-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-0271-1110d247fa046…a55b01930146…

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
A040245-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA1997-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040245-001AA

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 06:07:402026-07A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-083f01610625f2…
2019-09-15 20:21 UTC2019-09A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A040245-001CARISOPRODOL350MGTABLET / ORAL1997-09-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-08e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040245-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040245-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040245-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040245-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040245-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040245-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040245-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040245-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040245-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040245-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040245-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040245-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040245-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040245-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040245-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040245-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040245-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040245-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040245-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040245-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040245-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040245-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040245-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040245-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040245-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040245-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040245-001AA1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040245-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040245-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040245-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040245-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040245-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040245-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040245-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040245-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040245-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040245-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040245-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040245-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040245-001AA1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
780d53a1-1665-e26e-d112-85333c0c8a2eProduct name520220516
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0271-1Carisoprodol28 in 1 BOTTLETABLET281

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARISOPRODOLACTIVE INGREDIENT21925K482HCARISOPRODOL TABLET [REDPHARM DRUG INC.]1
CARISOPRODOLACTIVE MOIETY21925K482HCARISOPRODOL TABLET [REDPHARM DRUG INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARISOPRODOL TABLET [REDPHARM DRUG INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARISOPRODOL TABLET [REDPHARM DRUG INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARISOPRODOL TABLET [REDPHARM DRUG INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARISOPRODOL TABLET [REDPHARM DRUG INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0271CARISOPRODOL TABLET [REDPHARM DRUG INC.]1Legacy NDC, 1 package rows20110707_c6f62299-5cab-4251-8bc3-8239dbd6b48e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarisoprodolCARISOPRODOLChartwell RX, LLCa44a3dfc-a427-4584-a086-4bc0c538b1252025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040245
application number: ANDA040245

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSNc6f62299-5cab-4251-8bc3-8239dbd6b48e1
197446carisoprodol 350 MG Oral TabletSCDc6f62299-5cab-4251-8bc3-8239dbd6b48e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0271-16729602710128 in 1 BOTTLEHistorical