Methocarbamol

Product NDC
0615-8506
11-digit product format
006158506
Labeler code
0615
Product ID
0615-8506_ae34b391-aa06-4b23-b834-27718ed65757
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA213967
Marketing category
ANDA
Marketing start
2023-02-09
Substance
METHOCARBAMOL
Active strength
500 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 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
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 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213967-001METHOCARBAMOL750MGTABLET / 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…
2020-11-12 02:37 UTC2020-11A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-12c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-126a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213967-002METHOCARBAMOL500MGTABLET / ORALAA2023-02-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213967-001METHOCARBAMOL750MGTABLET / ORALAA2020-08-121c564ffb4f44…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 49 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2023-12-20 04:57 UTC2023-12A213967-002AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213967-001AA1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213967-002AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213967-001AA19b2671bbb829…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL500 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
32ea8117-4a35-4e2c-93bc-866544b2c3beAvailable 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
0615-8506-05Methocarbamol15 in 1 BLISTER PACKTABLET, FILM COATED152
0615-8506-39Methocarbamol30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8506METHOCARBAMOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]2Current NDC, 2 package rows20240814_32ea8117-4a35-4e2c-93bc-866544b2c3be.zip

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
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
ndc (product): 0615-8506
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 TabletPSN32ea8117-4a35-4e2c-93bc-866544b2c3be2
197944methocarbamol 750 MG Oral TabletPSN32ea8117-4a35-4e2c-93bc-866544b2c3be2
197943methocarbamol 500 MG Oral TabletSCD32ea8117-4a35-4e2c-93bc-866544b2c3be2
197944methocarbamol 750 MG Oral TabletSCD32ea8117-4a35-4e2c-93bc-866544b2c3be2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8506-050061585060515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8506-05) 2024-07-01NoNoCurrent
0615-8506-390061585063930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8506-39) 2024-04-11NoNoCurrent