Methocarbamol

Product NDC
76420-258
11-digit product format
764200258
Labeler code
76420
Product ID
76420-258_1ad285fe-2e2c-5b7a-e063-6294a90aaad0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA040489
Marketing category
ANDA
Marketing start
2019-08-15
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 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
A040489-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2003-01-29
A040489-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2003-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040489-001AA
A040489-002AA

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040489-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040489-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040489-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040489-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040489-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040489-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040489-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040489-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040489-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040489-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040489-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040489-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040489-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040489-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040489-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040489-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040489-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040489-002AA1782e0a99824c…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
5a9b1104-4c9a-4c8c-9e24-719a7b3a89d7Available 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
76420-258-10Methocarbamol100 in 1 BOTTLETABLET1003
76420-258-30Methocarbamol30 in 1 BOTTLETABLET303
76420-258-60Methocarbamol60 in 1 BOTTLETABLET603
76420-258-90Methocarbamol90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-258-10EA - Each76420-25803c90fdd-3130-4371-862e-cbad2751cd7a12023-04-07
76420-258-30EA - Each76420-25843a52c8a-1164-4841-890e-7bd34495347912023-04-07
76420-258-60EA - Each76420-2589fdc339a-2679-4968-8627-078c8ca7a2fc12023-04-07
76420-258-90EA - Each76420-258365e65b2-cae4-437b-8834-8a4992e16cea12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-258METHOCARBAMOL TABLET [ASCLEMED USA, INC.]3Current NDC, Legacy NDC, 4 package rows20240615_5a9b1104-4c9a-4c8c-9e24-719a7b3a89d7.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 3 · 50 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.3d4a2486-863e-4e9f-be3b-67882863e7d42026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.6b9ed3a4-46d5-462e-ac93-6b959b314d772026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.adb49cb7-8900-44dc-add0-22e2cd8235ac2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.0deb5368-ffdc-40fc-a97c-ba89b7a97e502026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutions9617e2b0-4255-4542-95ca-9ee1818ca4502026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLHAWAII REPACK, INC.8643032a-c491-4ae4-ac46-5e0c4c79dc5b2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutionscfdc0d68-00ad-44d6-b932-819cc3d5d60e2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutionsb81a8e64-ae41-409b-94a6-b36cb50bc25d2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLHAWAII REPACK, INC.c4744824-4c74-411d-aa8e-c63ee9d899132026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.4ef1c2c0-31e1-4f85-b645-ff47a057a9942026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals, Inc425abc3b-2111-4fac-bf27-b685d1e657af2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLDirect_rx4c5c8933-a4b5-f9c2-e063-6294a90a6f002026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack5af36a83-2b36-4fe2-8c6a-61b5516214212026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackcc004f5c-d5fc-48c5-9f37-c59b9c37e1132026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack9076b4ad-17be-4933-a975-7bf80cc92b492026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f8aed5d-ba8d-4c32-872b-08ab15240cc12026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLSt. Mary's Medical Park Pharmacyfd8cac57-9664-1fa0-e053-6294a90af8722026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack6466438c-4609-4554-8919-35710a1b556d2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack33f89a57-f65d-4e99-a3a3-690ef805d8692026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack6af87b4e-6507-4190-b043-a6d3b440314a2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN5a9b1104-4c9a-4c8c-9e24-719a7b3a89d73
197944methocarbamol 750 MG Oral TabletSCD5a9b1104-4c9a-4c8c-9e24-719a7b3a89d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-258-1076420025810100 TABLET in 1 BOTTLE (76420-258-10) 100 tablet2019-08-150000-00-00NoNoCurrent
76420-258-307642002583030 TABLET in 1 BOTTLE (76420-258-30) 30 tablet2019-08-150000-00-00NoNoCurrent
76420-258-607642002586060 TABLET in 1 BOTTLE (76420-258-60) 60 tablet2019-08-150000-00-00NoNoCurrent
76420-258-907642002589090 TABLET in 1 BOTTLE (76420-258-90) 90 tablet2019-08-150000-00-00NoNoCurrent