Carisoprodol

Product NDC
62135-241
11-digit product format
621350241
Labeler code
62135
Product ID
62135-241_458c539a-5c3d-0ecd-e063-6294a90a2de7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA040245
Marketing category
ANDA
Marketing start
2019-08-08
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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040245-001CARISOPRODOL350MGTABLET / ORALAA1997-09-0884e616aacf4f…
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…

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
2026-09-14 22:38:342026-08A040245-001AA184e616aacf4f…
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…

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
a44a3dfc-a427-4584-a086-4bc0c538b125Available 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
62135-241-12Carisoprodol120 in 1 BOTTLETABLET1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-241-12EA - Each62135-241bd4da232-d47e-43d9-a3cb-61b71cfc2edc12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-241CARISOPRODOL TABLET [CHARTWELL RX, LLC]4Current NDC, Legacy NDC, 1 package rows20241016_a44a3dfc-a427-4584-a086-4bc0c538b125.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
ndc (product): 62135-241

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSNa44a3dfc-a427-4584-a086-4bc0c538b1255
197446carisoprodol 350 MG Oral TabletSCDa44a3dfc-a427-4584-a086-4bc0c538b1255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-241-1262135024112120 TABLET in 1 BOTTLE (62135-241-12) 120 tablet2023-01-05NoNoCurrent