Carisoprodol

Product NDC
63629-4707
Requested package NDC
63629-4707-2
11-digit product format
636294707
Labeler code
63629
Product ID
63629-4707_d756a18e-3ea9-4e5a-bf12-f1d9ccd309b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA087499
Marketing category
ANDA
Marketing start
1987-11-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-470763629-4707-2DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A087499-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA1982-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A087499-001AA

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 22:38:342026-08A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-2084e616aacf4f…
2026-08-18 06:07:402026-07A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-203f01610625f2…
2019-09-15 20:21 UTC2019-09A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087499-001CARISOPRODOL350MGTABLET / ORALAA1982-04-20f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A087499-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A087499-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087499-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087499-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A087499-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087499-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087499-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087499-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087499-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087499-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087499-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087499-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087499-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087499-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087499-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087499-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087499-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087499-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087499-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087499-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087499-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087499-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087499-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A087499-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087499-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087499-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087499-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A087499-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087499-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087499-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087499-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087499-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087499-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087499-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087499-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087499-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087499-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087499-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087499-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087499-001AA1f41ea6bd6efb…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-4707-12020-10-16These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-22020-10-16These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-32020-10-16These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-42020-10-16These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-52020-10-16These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-62020-10-16These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-72020-10-16These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-82020-10-16These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-92020-10-16These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-12020-01-31These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-22020-01-31These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-32020-01-31These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-42020-01-31These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-52020-01-31These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-62020-01-31These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-72020-01-31These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-82020-01-31These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
63629-4707-92020-01-31These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4707-1EA - Each63629-470756be0cd6-67a7-46c9-8470-4ddc36387ffd12014-09-03
63629-4707-2EA - Each63629-47077d8f197f-4468-4d14-b661-be78f235f8a712014-09-03
63629-4707-3EA - Each63629-4707385ed024-3ef2-4905-8f5d-aa09a337480512014-09-03
63629-4707-4EA - Each63629-4707f24a9be8-2eed-47ce-aa61-3e988efa7fb512014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARISOPRODOLACTIVE INGREDIENT21925K482HCARISOPRODOL TABLET [BRYANT RANCH PREPACK]1000
CARISOPRODOLACTIVE MOIETY21925K482HCARISOPRODOL TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCARISOPRODOL TABLET [BRYANT RANCH PREPACK]1000
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0CARISOPRODOL TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARISOPRODOL TABLET [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARISOPRODOL TABLET [BRYANT RANCH PREPACK]1000
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCARISOPRODOL TABLET [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARISOPRODOL TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARISOPRODOL TABLET [BRYANT RANCH PREPACK]1000

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4707-26362947070230 TABLET in 1 BOTTLE (63629-4707-2) 30 tablet2012-05-030000-00-00NoNoCurrent