CARISOPRODOL

Product NDC
43353-102
Requested package NDC
43353-102-70
11-digit product format
433530102
Labeler code
43353
Product ID
43353-102_b2f0e725-2fa9-4990-8039-56cd8ca277bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARISOPRODOL
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203374
Marketing category
ANDA
Marketing start
2014-02-20
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
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43353-10243353-102-70IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-102-30CARISOPRODOL30 in 1 BOTTLETABLET304
43353-102-53CARISOPRODOL60 in 1 BOTTLETABLET604
43353-102-60CARISOPRODOL90 in 1 BOTTLETABLET904
43353-102-70CARISOPRODOL120 in 1 BOTTLETABLET1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-102-30EA - Each43353-102b05cb13b-b88c-4261-9209-17d75cf1451112016-09-02
43353-102-53EA - Each43353-10254c4f194-ddb0-4d88-aee2-5b05aee55f2812016-07-19
43353-102-60EA - Each43353-102f60bc5c2-b3a8-4241-8fcd-a0771ac9775612016-07-19
43353-102-70EA - Each43353-102056c35c6-1532-4cf5-a4ba-bcb4934787b612016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-102CARISOPRODOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 4 package rows20191221_26261935-85fb-4c6f-b69c-6d6684774e28.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 TabletPSN26261935-85fb-4c6f-b69c-6d6684774e284
197446carisoprodol 350 MG Oral TabletSCD26261935-85fb-4c6f-b69c-6d6684774e284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-102-7043353010270120 TABLET in 1 BOTTLE (43353-102-70) 120 tablet2015-09-190000-00-00NoNoCurrent