Carisoprodol Tablets, USP, 350 mg

Product NDC
72162-2525
11-digit product format
721622525
Labeler code
72162
Product ID
72162-2525_ad5c9fff-69c8-40a5-97a0-6a51d35fb9d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211789
Marketing category
ANDA
Marketing start
2025-06-11
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
A211789-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA2021-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211789-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211789-001CARISOPRODOL350MGTABLET / ORAL2021-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211789-001CARISOPRODOL350MGTABLET / ORAL2021-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211789-001CARISOPRODOL350MGTABLET / ORAL2021-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211789-001CARISOPRODOL350MGTABLET / ORAL2021-10-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211789-001CARISOPRODOL350MGTABLET / ORAL2021-10-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-204b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211789-001CARISOPRODOL350MGTABLET / ORALAA2021-10-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211789-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211789-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211789-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211789-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211789-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211789-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211789-001AA103ed91905a0d…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211789-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211789-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211789-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211789-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211789-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211789-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211789-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211789-001AA1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211789-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211789-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211789-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211789-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211789-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211789-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211789-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211789-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211789-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211789-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211789-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211789-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211789-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211789-001AA1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Carisoprodol Tablets, USP, 350 mg
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
409b04af-b9fd-4ba5-afa0-3e43466f8d2dAvailable 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
72162-2525-0Carisoprodol Tablets, USP, 350 mg1000 in 1 BOTTLETABLET1000101
72162-2525-1Carisoprodol Tablets, USP, 350 mg100 in 1 BOTTLETABLET100101
72162-2525-2Carisoprodol Tablets, USP, 350 mg100 in 1 BOTTLETABLET100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2525-0EA - Each72162-2525a8fea7cf-ced1-4bd9-8b17-066861ee862b12025-08-11
72162-2525-1EA - Each72162-25254afba1f5-adc0-4506-96f8-b9133db80a4a12025-08-11
72162-2525-2EA - Each72162-2525d2bec6fa-bb87-4646-bde5-68574f1cc75312026-01-08

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLBryant Ranch Prepack35a8e0a4-93a3-44e3-903f-4661ee1cffe82025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211789
application number: ANDA211789
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLBryant Ranch Prepack409b04af-b9fd-4ba5-afa0-3e43466f8d2d2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211789
application number: ANDA211789
ndc (product): 72162-2525
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLPD-Rx Pharmaceuticals, Inc.1f08f4af-37c2-49b5-a4e3-284414f866fa2025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211789
application number: ANDA211789
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLGranulation Technology, Inc.2abd11e4-8ce4-4aeb-87c4-3af94c1977142025-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211789
application number: ANDA211789

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN409b04af-b9fd-4ba5-afa0-3e43466f8d2d101
197446carisoprodol 350 MG Oral TabletSCD409b04af-b9fd-4ba5-afa0-3e43466f8d2d101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2525-0721622525001000 TABLET in 1 BOTTLE (72162-2525-0) 1000 tablet2025-07-22NoNoCurrent
72162-2525-172162252501100 TABLET in 1 BOTTLE (72162-2525-1) 100 tablet2025-07-22NoNoCurrent
72162-2525-272162252502100 TABLET in 1 BOTTLE (72162-2525-2) 100 tablet2025-07-22NoNoCurrent