Carisoprodol

Product NDC
69584-111
11-digit product format
695840111
Labeler code
69584
Product ID
69584-111_c2798091-3c51-4962-b72d-f11592ec00f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Oxford Pharmaceuticals, LLC
Application
ANDA040188
Marketing category
ANDA
Marketing start
2020-01-20
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
A040188-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA1997-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040188-001AA

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 06:07:402026-07A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040188-001CARISOPRODOL350MGTABLET / ORAL1997-03-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040188-001CARISOPRODOL350MGTABLET / ORAL1997-03-073f01610625f2…
2019-09-15 20:21 UTC2019-09A040188-001CARISOPRODOL350MGTABLET / ORAL1997-03-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A040188-001CARISOPRODOL350MGTABLET / ORAL1997-03-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040188-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040188-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040188-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040188-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040188-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040188-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040188-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040188-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040188-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040188-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040188-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040188-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040188-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040188-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040188-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040188-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040188-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040188-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A040188-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040188-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040188-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040188-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040188-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040188-001AA1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040188-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040188-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040188-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040188-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040188-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040188-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040188-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040188-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040188-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040188-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040188-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040188-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040188-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040188-001AA1a50c72e98297…

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
03c3455f-e217-4a7e-908f-609333dc35fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
69584-111-10Carisoprodol100 in 1 BOTTLETABLET1002
69584-111-50Carisoprodol500 in 1 BOTTLETABLET5002
69584-111-90Carisoprodol1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-111-10EA - Each69584-1111d0dcd41-fb7e-4abc-9690-f969712356cf12020-03-10
69584-111-50EA - Each69584-111dfd23372-5d36-466f-8478-c08043eaa25812020-07-13
69584-111-90EA - Each69584-111d17e4746-5908-492b-87f5-80b3fbc878e612020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-111CARISOPRODOL TABLET [OXFORD PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 3 package rows20241228_03c3455f-e217-4a7e-908f-609333dc35fc.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarisoprodolCARISOPRODOLREMEDYREPACK INC.b83f7fd1-11e3-4e94-ae53-4637e892b3722026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CARISOPRODOLCARISOPRODOLDirectrxd5cc9f99-59ae-55db-e053-2995a90affb72026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLA-S Medication Solutions6c15f559-c045-4271-86ef-e001aad39c332026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLA-S Medication Solutions88f9b969-4225-49d6-9e4c-8c397ba7b50c2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLPD-Rx Pharmaceuticals, Inc.4626a7a7-c433-4dab-8deb-e6e45de493a62025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLPD-Rx Pharmaceuticals, Inc.9d251c26-c893-425a-b8ac-20c06e50e80c2025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLBryant Ranch Prepackf8aee817-c652-441e-b99a-8cbc4e6d06ef2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLBryant Ranch Prepack95e13b8c-3558-43f0-b888-90978db878fb2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLBryant Ranch Prepackacc7f959-55ac-4d9b-8ef4-4538378364e62025-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLOxford Pharmaceuticals, LLC03c3455f-e217-4a7e-908f-609333dc35fc2024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 69584-111
CarisoprodolCARISOPRODOLMedsource Pharmaceuticals125023cb-45c2-1685-e063-6394a90af0892024-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLAphena Pharma Solutions - Tennessee, LLC2484de44-b36a-421c-a4d9-64c2016947542023-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLProficient Rx LPb04fbd67-9ac5-4043-87e9-c3804d1e5d0c2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLAphena Pharma Solutions - Tennessee, LLC2179f18b-df15-4bf6-a7c7-6d9960f49a422021-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSNacc7f959-55ac-4d9b-8ef4-4538378364e6103
197446carisoprodol 350 MG Oral TabletSCDacc7f959-55ac-4d9b-8ef4-4538378364e6103
197446carisoprodol 350 MG Oral TabletPSN95e13b8c-3558-43f0-b888-90978db878fb102
197446carisoprodol 350 MG Oral TabletSCD95e13b8c-3558-43f0-b888-90978db878fb102
197446carisoprodol 350 MG Oral TabletPSNf8aee817-c652-441e-b99a-8cbc4e6d06ef101
197446carisoprodol 350 MG Oral TabletSCDf8aee817-c652-441e-b99a-8cbc4e6d06ef101
197446carisoprodol 350 MG Oral TabletPSNb83f7fd1-11e3-4e94-ae53-4637e892b37214
197446carisoprodol 350 MG Oral TabletSCDb83f7fd1-11e3-4e94-ae53-4637e892b37214
197446carisoprodol 350 MG Oral TabletPSN4626a7a7-c433-4dab-8deb-e6e45de493a69
197446carisoprodol 350 MG Oral TabletSCD4626a7a7-c433-4dab-8deb-e6e45de493a69
197446carisoprodol 350 MG Oral TabletPSN9d251c26-c893-425a-b8ac-20c06e50e80c8
197446carisoprodol 350 MG Oral TabletSCD9d251c26-c893-425a-b8ac-20c06e50e80c8
197446carisoprodol 350 MG Oral TabletPSNd5cc9f99-59ae-55db-e053-2995a90affb76
197446carisoprodol 350 MG Oral TabletSCDd5cc9f99-59ae-55db-e053-2995a90affb76
197446carisoprodol 350 MG Oral TabletPSN88f9b969-4225-49d6-9e4c-8c397ba7b50c5
197446carisoprodol 350 MG Oral TabletPSN6c15f559-c045-4271-86ef-e001aad39c335
197446carisoprodol 350 MG Oral TabletSCD88f9b969-4225-49d6-9e4c-8c397ba7b50c5
197446carisoprodol 350 MG Oral TabletSCD6c15f559-c045-4271-86ef-e001aad39c335
197446carisoprodol 350 MG Oral TabletPSN2484de44-b36a-421c-a4d9-64c2016947542
197446carisoprodol 350 MG Oral TabletPSN03c3455f-e217-4a7e-908f-609333dc35fc2
197446carisoprodol 350 MG Oral TabletSCD2484de44-b36a-421c-a4d9-64c2016947542
197446carisoprodol 350 MG Oral TabletSCD03c3455f-e217-4a7e-908f-609333dc35fc2
197446carisoprodol 350 MG Oral TabletPSN125023cb-45c2-1685-e063-6394a90af0891
197446carisoprodol 350 MG Oral TabletPSNb04fbd67-9ac5-4043-87e9-c3804d1e5d0c1
197446carisoprodol 350 MG Oral TabletSCD125023cb-45c2-1685-e063-6394a90af0891
197446carisoprodol 350 MG Oral TabletSCDb04fbd67-9ac5-4043-87e9-c3804d1e5d0c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69584-111-1069584011110100 TABLET in 1 BOTTLE (69584-111-10) 100 tablet2020-01-200000-00-00NoNoCurrent
69584-111-5069584011150500 TABLET in 1 BOTTLE (69584-111-50) 500 tablet2020-01-200000-00-00NoNoCurrent
69584-111-90695840111901000 TABLET in 1 BOTTLE (69584-111-90) 1000 tablet2020-01-200000-00-00NoNoCurrent