Methocarbamol

Product NDC
63629-1124
11-digit product format
636291124
Labeler code
63629
Product ID
63629-1124_f3bf076f-eef7-469c-bf57-c036f03fb611
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA086988
Marketing category
ANDA
Marketing start
2013-01-15
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1124DDiscontinued by firm2026-08-03
excluded packagepackage63629-112463629-1124-1DDiscontinued by firm2026-08-03

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1124-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1124-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1124-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1124-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1124-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1124-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1124-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1124-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-1124-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-1124-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-1124-1367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A086988-001METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAAApproved before 1982
A086988-002METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAAApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A086988-001AA
A086988-002AA

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 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A086988-002METHOCARBAMOL500MGTABLET / ORALAAApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A086988-001METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982b00525d2431f…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A086988-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086988-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086988-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086988-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A086988-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086988-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086988-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086988-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086988-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086988-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086988-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086988-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086988-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086988-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086988-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086988-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086988-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086988-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086988-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A086988-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086988-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086988-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086988-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086988-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086988-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086988-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086988-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A086988-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086988-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086988-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086988-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086988-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086988-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086988-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086988-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A086988-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086988-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086988-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086988-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A086988-001AA1b00525d2431f…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1124-1EA - Each63629-11240eb8fcd5-f130-45c8-b4ce-e84026c3a58112020-09-14

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLCardinal Health 107, LLC50603730-9f69-4ed7-bccf-31c474f83e142026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086988
application number: ANDA086988
MethocarbamolMETHOCARBAMOLMajor Pharmaceuticals2df34fa7-9cdc-4be4-ac6f-5771224626062026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086988
application number: ANDA086988
MethocarbamolMETHOCARBAMOLSolco Healthcare LLC32863f21-30ff-4a8b-a2e6-8ab14a37af0d2025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086988
application number: ANDA086988
MethocarbamolMETHOCARBAMOLREMEDYREPACK INC.87ff444e-d502-428c-8be7-89d36c0cf7092025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086988
application number: ANDA086988
MethocarbamolMETHOCARBAMOLGolden State Medical Supply, Inc.c67d3e2b-92cd-1b97-e053-2a95a90af36f2025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086988
application number: ANDA086988
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack4003026f-ed9e-40ac-9e7e-5e28d32d7cb82023-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086988
application number: ANDA086988
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackb415184c-1603-4a86-92d2-746f8d3d3f3c2023-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086988
application number: ANDA086988
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC27c39343-44e0-4ca6-a67f-1e6d11dd67992021-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086988
application number: ANDA086988
MethocarbamolMETHOCARBAMOLProficient Rx LP0003eccd-6147-4a7c-ae83-b2a94933e07d2020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086988
application number: ANDA086988

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1124-163629112401100 TABLET in 1 BOTTLE (63629-1124-1) 100 tablet2020-07-300000-00-00NoNoCurrent