CARISOPRODOL

Product NDC
60760-397
11-digit product format
607600397
Labeler code
60760
Product ID
60760-397_45366e25-cf63-170a-e063-6394a90a2530
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARISOPRODOL
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA203374
Marketing category
ANDA
Marketing start
2019-10-15
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
2026-12-31
Current FDA listing
Yes

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 · 24 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 packagepackage60760-397-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60760-397-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60760-397-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60760-397-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60760-397-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60760-397-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60760-397-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60760-397-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60760-397-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60760-397-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60760-397-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60760-397-90557ba5c1ecfa…9c80585c8c6e…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
CARISOPRODOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARISOPRODOL350 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
21925K482HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197446Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
94f74800-1f0d-7814-e053-2a95a90a4f63Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-397-90CARISOPRODOL90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-397-90EA - Each60760-3974c9f77c8-59bc-4608-a368-bb4a646b90ad12019-11-12

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
ndc (product): 60760-397
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 TabletPSN94f74800-1f0d-7814-e053-2a95a90a4f633
197446carisoprodol 350 MG Oral TabletSCD94f74800-1f0d-7814-e053-2a95a90a4f633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-397-906076003979090 TABLET in 1 BOTTLE, PLASTIC (60760-397-90) 90 tablet2025-12-010000-00-00NoNoCurrent