CARISOPRODOL

Product NDC
50742-656
11-digit product format
507420656
Labeler code
50742
Product ID
50742-656_372a2c87-8153-403b-8f40-851e1dddd809
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARISOPRODOL
Dosage form
TABLET
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA040823
Marketing category
ANDA
Marketing start
2019-05-21
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
A040823-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA2008-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040823-001AA

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 06:07:402026-07A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-223f01610625f2…
2019-09-15 20:21 UTC2019-09A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040823-001CARISOPRODOL350MGTABLET / ORALAA2008-10-22e64feba35796…

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 06:07:402026-07A040823-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040823-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040823-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040823-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040823-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040823-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040823-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040823-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040823-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040823-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040823-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040823-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040823-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040823-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040823-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040823-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040823-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040823-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040823-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040823-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040823-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040823-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040823-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040823-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040823-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040823-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040823-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040823-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040823-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040823-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040823-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040823-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040823-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040823-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040823-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040823-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040823-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040823-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040823-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040823-001AA1e64feba35796…

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
5eff5b4c-c363-45b5-9eef-b724233a51e2Available 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
50742-656-01CARISOPRODOL100 in 1 BOTTLETABLET1003
50742-656-05CARISOPRODOL500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-656-01EA - Each50742-656be6fac9b-3d1e-4b1e-8e71-17e65cb140d112019-07-02
50742-656-05EA - Each50742-656ada941e0-ea65-4189-ab1b-4d6b86dbd8e812019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-656CARISOPRODOL TABLET [INGENUS PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 2 package rows20240523_5eff5b4c-c363-45b5-9eef-b724233a51e2.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
CARISOPRODOLCARISOPRODOLIngenus Pharmaceuticals, LLC5eff5b4c-c363-45b5-9eef-b724233a51e22023-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040823
application number: ANDA040823
ndc (product): 50742-656

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN5eff5b4c-c363-45b5-9eef-b724233a51e23
197446carisoprodol 350 MG Oral TabletSCD5eff5b4c-c363-45b5-9eef-b724233a51e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-656-0150742065601100 TABLET in 1 BOTTLE (50742-656-01) 100 tablet2019-05-210000-00-00NoNoCurrent
50742-656-0550742065605500 TABLET in 1 BOTTLE (50742-656-05) 500 tablet2019-05-210000-00-00NoNoCurrent