Methocarbamol

Product NDC
69543-135
11-digit product format
695430135
Labeler code
69543
Product ID
69543-135_80d903de-b812-478c-8124-95a9dc55f1a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Virtus Pharmaceuticals
Application
ANDA200958
Marketing category
ANDA
Marketing start
2015-07-13
Marketing end
2020-11-30
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69543-135DDiscontinued by firm2026-08-03
excluded packagepackage69543-13569543-135-10DDiscontinued by firm2026-08-03
excluded packagepackage69543-13569543-135-50DDiscontinued 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 · 36 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 packagepackage69543-135-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69543-135-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69543-135-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69543-135-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69543-135-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69543-135-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69543-135-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69543-135-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69543-135-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69543-135-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69543-135-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69543-135-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69543-135-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69543-135-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69543-135-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69543-135-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69543-135-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69543-135-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69543-135-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69543-135-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69543-135-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69543-135-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69543-135-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69543-135-10557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200958-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2011-10-21
A200958-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2011-10-21
A200958-003METHOCARBAMOLMETHOCARBAMOL1GMTABLET / ORALABRS2021-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A200958-001AA
A200958-002AA
A200958-003AB

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 3 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 103 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200958-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200958-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200958-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200958-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200958-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200958-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200958-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200958-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200958-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200958-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200958-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200958-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200958-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200958-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200958-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200958-001AA18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-135-10EA - Each69543-135c85e92a4-c211-4f46-872b-f0d801397a9e12015-10-02
69543-135-50EA - Each69543-1350cd3f83c-2403-46f9-8f46-e55b0cbb576a12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MethocarbamolACTIVE INGREDIENT125OD7737XMETHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
MethocarbamolACTIVE MOIETY125OD7737XMETHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933METHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMETHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48METHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8METHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
ferric oxide redINACTIVE INGREDIENT1K09F3G675METHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTMETHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
hydroxypropyl cellulose (type h)INACTIVE INGREDIENTRFW2ET671PMETHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMETHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
magnesium stearateINACTIVE INGREDIENT70097M6I30METHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AMETHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMETHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2
triacetinINACTIVE INGREDIENTXHX3C3X673METHOCARBAMOL TABLET, FILM COATED [VIRTUS PHARMACEUTICALS]2

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
MethocarbamolMETHOCARBAMOLMisemer Pharmaceuticale89ae224-ed25-4ae7-e053-2a95a90a9c0e2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200958
application number: ANDA200958
MethocarbamolMETHOCARBAMOLBostal LLCd8f10211-f96e-4cf3-9b49-986eb51b703d2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200958
application number: ANDA200958
MethocarbamolMETHOCARBAMOLOncora Pharma, LLC440d6c99-8aca-af07-e063-6294a90aee3d2025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200958
application number: ANDA200958
MethocarbamolMETHOCARBAMOLTrifluent Pharma LLCde2e3af9-03ab-4dc8-b480-6866474ad1bd2025-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200958
application number: ANDA200958

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN33209430-6d77-1c13-e054-00144ff8d46c1
1010654robaxin-750 750 MG Oral TabletPSN33209430-6d77-1c13-e054-00144ff8d46c1
1010654methocarbamol 750 MG Oral Tablet [Robaxin]SBD33209430-6d77-1c13-e054-00144ff8d46c1
197944methocarbamol 750 MG Oral TabletSCD33209430-6d77-1c13-e054-00144ff8d46c1
1010654Robaxin 750 MG Oral TabletSY33209430-6d77-1c13-e054-00144ff8d46c1