Carisoprodol

Product NDC
69367-419
11-digit product format
693670419
Labeler code
69367
Product ID
69367-419_829cccf4-83d3-48d3-93a3-4e1ec01664ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA207237
Marketing category
ANDA
Marketing start
2025-11-25
Substance
CARISOPRODOL
Active strength
250 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207237-001CARISOPRODOLCARISOPRODOL250MGTABLET / ORALAB2017-05-11
A207237-002CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA2020-09-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207237-001AB
A207237-002AA

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 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207237-002CARISOPRODOL350MGTABLET / ORALAA2020-09-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207237-001CARISOPRODOL250MGTABLET / ORALAB2017-05-11782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207237-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207237-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207237-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207237-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207237-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207237-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207237-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207237-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207237-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207237-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207237-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207237-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207237-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207237-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207237-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207237-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207237-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207237-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207237-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207237-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207237-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207237-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207237-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207237-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207237-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207237-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207237-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207237-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207237-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207237-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207237-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207237-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207237-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207237-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207237-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207237-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207237-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207237-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207237-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207237-001AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Carisoprodol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARISOPRODOL250 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197446Internal RxNorm lookup
730794Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bfb31551-8c57-4360-be3a-f6fbe84a891eAvailable 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
69367-419-01Carisoprodol100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-419-01EA - Each69367-419332fc679-1885-4d50-ae2f-9ce0fb674a6712026-02-05

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarisoprodolCARISOPRODOLWestminster Pharmaceuticals, LLCbfb31551-8c57-4360-be3a-f6fbe84a891e2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207237
application number: ANDA207237
ndc (product): 69367-419
CarisoprodolCARISOPRODOLBryant Ranch Prepack8c0c418c-90e2-4b81-a9c0-b131c38ec8742025-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207237
application number: ANDA207237
CarisoprodolCARISOPRODOLBryant Ranch Prepack8079db44-70d4-4daf-b4b7-89d0e0f384702024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207237
application number: ANDA207237

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
730794carisoprodol 250 MG Oral TabletPSNbfb31551-8c57-4360-be3a-f6fbe84a891e2
197446carisoprodol 350 MG Oral TabletPSNbfb31551-8c57-4360-be3a-f6fbe84a891e2
730794carisoprodol 250 MG Oral TabletSCDbfb31551-8c57-4360-be3a-f6fbe84a891e2
197446carisoprodol 350 MG Oral TabletSCDbfb31551-8c57-4360-be3a-f6fbe84a891e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-419-0169367041901100 TABLET in 1 BOTTLE (69367-419-01) 100 tablet2025-11-25NoNoCurrent