CARISOPRODOL

Product NDC
42543-700
11-digit product format
425430700
Labeler code
42543
Product ID
42543-700_51dfd284-b3d8-4b5c-b8d4-b93a070ddb2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARISOPRODOL
Dosage form
TABLET
Route
ORAL
Labeler
Vensun Pharmaceuticals, Inc.
Application
ANDA203374
Marketing category
ANDA
Marketing start
2014-07-31
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

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
2026-12-31

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
7c6015ad-2158-400d-8c22-585ab277ea49Available 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
42543-700-01CARISOPRODOL100 in 1 BOTTLETABLET1005
42543-700-05CARISOPRODOL500 in 1 BOTTLETABLET5005
42543-700-10CARISOPRODOL1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-700-01EA - Each42543-70067c78e39-df17-40c6-ae48-ca2c99a1e33e12014-09-03
42543-700-05EA - Each42543-700e76af91b-61dd-4132-96e7-9e98657f927f12014-09-03
42543-700-10EA - Each42543-700cc33f54b-c034-4c15-a195-b3f43f4ef76312014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARISOPRODOLACTIVE INGREDIENT21925K482HCARISOPRODOL TABLET [VENSUN PHARMACEUTICALS, INC.]2
CARISOPRODOLACTIVE MOIETY21925K482HCARISOPRODOL TABLET [VENSUN PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARISOPRODOL TABLET [VENSUN PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARISOPRODOL TABLET [VENSUN PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARISOPRODOL TABLET [VENSUN PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARISOPRODOL TABLET [VENSUN PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARISOPRODOL TABLET [VENSUN PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARISOPRODOL TABLET [VENSUN PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARISOPRODOL TABLET [VENSUN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-700CARISOPRODOL TABLET [VENSUN PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20181114_7c6015ad-2158-400d-8c22-585ab277ea49.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
ndc (product): 42543-700

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN50d4d542-d0bf-40cd-e054-00144ff88e885
197446carisoprodol 350 MG Oral TabletPSN7c6015ad-2158-400d-8c22-585ab277ea495
197446carisoprodol 350 MG Oral TabletSCD50d4d542-d0bf-40cd-e054-00144ff88e885
197446carisoprodol 350 MG Oral TabletSCD7c6015ad-2158-400d-8c22-585ab277ea495
197446carisoprodol 350 MG Oral TabletPSN89359f53-fd7e-4e31-a3fc-96f75c5f39972
197446carisoprodol 350 MG Oral TabletPSNefd7a0b4-5ec5-4929-a4cb-7d207171eed62
197446carisoprodol 350 MG Oral TabletSCD89359f53-fd7e-4e31-a3fc-96f75c5f39972
197446carisoprodol 350 MG Oral TabletSCDefd7a0b4-5ec5-4929-a4cb-7d207171eed62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42543-700-0142543070001100 TABLET in 1 BOTTLE (42543-700-01) 100 tablet2014-07-310000-00-00NoNoCurrent
42543-700-0542543070005500 TABLET in 1 BOTTLE (42543-700-05) 500 tablet2014-07-310000-00-00NoNoCurrent
42543-700-10425430700101000 TABLET in 1 BOTTLE (42543-700-10) 1000 tablet2014-07-310000-00-00NoNoCurrent