CARISOPRODOL

Product NDC
67296-1404
11-digit product format
672961404
Labeler code
67296
Product ID
67296-1404_d61fb787-346c-52ac-e053-2995a90a80a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARISOPRODOL
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA203374
Marketing category
ANDA
Marketing start
2014-07-31
Marketing end
0000-00-00
Substance
CARISOPRODOL
Active strength
350 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
DEA schedule
CIV
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1404IInactivated by FDA2026-08-17
excluded packagepackage67296-140467296-1404-1IInactivated 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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-1404-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1404-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1404-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1404-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1404-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1404-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1404-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1404-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1404-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-1404-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-1404-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1404-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1404-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1404-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1404-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-1404-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
A203374-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA2014-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203374-001AA

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 06:07:402026-07A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-273f01610625f2…
2019-09-15 20:21 UTC2019-09A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203374-001CARISOPRODOL350MGTABLET / ORALAA2014-01-27e64feba35796…

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 06:07:402026-07A203374-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203374-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203374-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203374-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203374-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203374-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203374-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203374-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203374-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203374-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203374-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203374-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203374-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203374-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203374-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203374-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203374-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203374-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203374-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203374-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203374-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203374-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A203374-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203374-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203374-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203374-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A203374-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203374-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203374-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203374-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203374-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203374-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203374-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203374-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203374-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203374-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203374-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203374-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203374-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203374-001AA1e64feba35796…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1404-12024-01-30C16284748780-11030e365-0e39-111a-e063-dadaa90a10e250d4d542-d0bf-40cd-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1404-1CARISOPRODOL28 in 1 BOTTLETABLET285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1404CARISOPRODOL TABLET [REDPHARM DRUG, INC.]5Legacy NDC, 1 package rows20220123_50d4d542-d0bf-40cd-e054-00144ff88e88.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARISOPRODOLCARISOPRODOLNorthwind Health Company, LLC26e466be-8066-e562-e063-6394a90a9f812026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLSt. Mary's Medical Park Pharmacy94f74800-1f0d-7814-e053-2a95a90a4f632026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack269644bf-d32c-48a3-b3eb-1221150ebd222026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack59f6f0e3-fdbd-4788-9944-37edde4b9a3c2026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLBryant Ranch Prepacka3f1343f-1337-4b99-b1ae-4189324ec2e92026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack93f909ea-2d2e-4a10-be50-7f33f3e904d42026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLScieGen Pharmaceuticals, Inc.069ea892-21a6-4703-8dd3-bf19c44064792026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CarisoprodolCARISOPRODOLDirect_Rx8e9bb49a-8cc3-4390-e053-2a95a90a4e0e2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CarisoprodolCARISOPRODOLAdvanced Rx Pharmacy of Tennessee, LLCf835e66e-f3f3-c3cf-e053-6294a90addf22024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLBryant Ranch Prepackfdd6318f-399f-499c-acdc-5318aa080f362024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLNuCare Pharmaceuticals,Inc.93cbe188-5443-b392-e053-2995a90a9ac72024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLAsclemed USA, Inc.4221d7d1-d7d6-46c4-be41-8c8e991293242023-11-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLProficient Rx LP2178e805-8189-459f-a447-21bf1547744a2022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLProficient Rx LPefd7a0b4-5ec5-4929-a4cb-7d207171eed62019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374
CARISOPRODOLCARISOPRODOLVensun Pharmaceuticals, Inc.7c6015ad-2158-400d-8c22-585ab277ea492018-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203374
application number: ANDA203374

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN50d4d542-d0bf-40cd-e054-00144ff88e885
197446carisoprodol 350 MG Oral TabletSCD50d4d542-d0bf-40cd-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1404-16729614040128 TABLET in 1 BOTTLE (67296-1404-1) 28 tablet2014-07-310000-00-00NoNoCurrent