Methocarbamol

Product NDC
87063-041
11-digit product format
870630041
Labeler code
87063
Product ID
87063-041_445114b8-5b56-c48d-e063-6294a90a31d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA213967
Marketing category
ANDA
Marketing start
2020-08-12
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
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 43.

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
A213967-001METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2020-08-12
A213967-002METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2023-02-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213967-001AA
A213967-002AA

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 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-1284e616aacf4f…
2026-09-14 22:38:342026-08A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-0984e616aacf4f…
2026-08-18 06:07:402026-07A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-12caaa826d4ba7…
2026-08-18 06:07:402026-07A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213967-001METHOCARBAMOL750MGTABLET / ORAL2020-08-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213967-001METHOCARBAMOL750MGTABLET / ORAL2020-08-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213967-001METHOCARBAMOL750MGTABLET / ORAL2020-08-124b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213967-001METHOCARBAMOL750MGTABLET / ORAL2020-08-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213967-001METHOCARBAMOL750MGTABLET / ORAL2020-08-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213967-001METHOCARBAMOL750MGTABLET / ORAL2020-08-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-128869cabd3fbd…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213967-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A213967-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A213967-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A213967-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213967-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213967-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213967-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213967-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213967-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213967-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213967-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213967-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213967-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213967-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213967-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213967-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213967-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213967-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213967-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213967-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213967-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213967-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213967-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213967-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213967-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213967-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213967-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213967-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213967-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213967-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213967-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213967-002AA18072bd15b7f6…
2021-03-12 10:30 UTC2021-03A213967-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213967-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213967-001AA1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213967-001AA16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213967-002AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213967-001AA11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213967-002AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213967-001AA1ea1830bbd6c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL750 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
125OD7737XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197943Internal RxNorm lookup
197944Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7f297ac6-a580-4539-a770-fe5d15c2b922Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87063-041-01Methocarbamol100 in 1 BOTTLETABLET, FILM COATED1001
87063-041-10Methocarbamol10 in 1 BOTTLETABLET, FILM COATED101
87063-041-20Methocarbamol20 in 1 BOTTLETABLET, FILM COATED201
87063-041-30Methocarbamol30 in 1 BOTTLETABLET, FILM COATED301
87063-041-60Methocarbamol60 in 1 BOTTLETABLET, FILM COATED601
87063-041-90Methocarbamol90 in 1 BOTTLETABLET, FILM COATED901

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLSt. Mary's Medical Park Pharmacy56090def-7caf-e916-e063-6294a90a6ac22026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967
MethocarbamolMETHOCARBAMOLRedpharm Drug44f2aa92-4619-021e-e063-6394a90a296c2026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967
MethocarbamolMETHOCARBAMOLSportpharm LLC64a06ef2-a062-49cc-9526-03c22b6ced2c2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals,Inc.36c2c31c-8648-7723-e063-6294a90aec982026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967
MethocarbamolMETHOCARBAMOLAsclemed USA, Inc.7f297ac6-a580-4539-a770-fe5d15c2b9222025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967
ndc (product): 87063-041
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackf7ab7f11-9b5a-4d3a-a8fc-eee55b1fc0062025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackfdea0332-1ad8-40ef-8cb9-b3c46588155d2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967
MethocarbamolMETHOCARBAMOLPHOENIX RX LLC3b199152-bafc-e14a-e063-6394a90ab2832025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.9169399e-bca1-4c44-9a93-886f3650e44d2025-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.38d8b457-0c0f-45cb-bf90-965c5a01b1982025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967
MethocarbamolMETHOCARBAMOLNCS HealthCare of KY, LLC dba Vangard Labs32ea8117-4a35-4e2c-93bc-866544b2c3be2024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967
MethocarbamolMETHOCARBAMOLAurobindo Pharma Limitedf83dd093-ea53-44c1-a40d-682ebc494b622024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213967
application number: ANDA213967

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN7f297ac6-a580-4539-a770-fe5d15c2b9221
197944methocarbamol 750 MG Oral TabletPSN7f297ac6-a580-4539-a770-fe5d15c2b9221
197943methocarbamol 500 MG Oral TabletSCD7f297ac6-a580-4539-a770-fe5d15c2b9221
197944methocarbamol 750 MG Oral TabletSCD7f297ac6-a580-4539-a770-fe5d15c2b9221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87063-041-0187063004101100 TABLET, FILM COATED in 1 BOTTLE (87063-041-01) 2025-11-24NoNoCurrent
87063-041-108706300411010 TABLET, FILM COATED in 1 BOTTLE (87063-041-10) 2025-11-24NoNoCurrent
87063-041-208706300412020 TABLET, FILM COATED in 1 BOTTLE (87063-041-20) 2025-11-24NoNoCurrent
87063-041-308706300413030 TABLET, FILM COATED in 1 BOTTLE (87063-041-30) 2025-11-24NoNoCurrent
87063-041-608706300416060 TABLET, FILM COATED in 1 BOTTLE (87063-041-60) 2025-11-24NoNoCurrent
87063-041-908706300419090 TABLET, FILM COATED in 1 BOTTLE (87063-041-90) 2025-11-24NoNoCurrent