Methocarbamol

Product NDC
55154-2334
11-digit product format
551542334
Labeler code
55154
Product ID
55154-2334_d2bee608-2530-4376-a66c-5c97b6348376
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA086988
Marketing category
ANDA
Marketing start
2017-12-15
Substance
METHOCARBAMOL
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol
Listing expiration
2027-12-31

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
50603730-9f69-4ed7-bccf-31c474f83e14Available 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
55154-2334-0Methocarbamol10 in 1 BAGTABLET108
55154-2334-0Methocarbamol1 in 1 BLISTER PACKTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2334METHOCARBAMOL TABLET [CARDINAL HEALTH 107, LLC]6Current NDC, Legacy NDC, 2 package rows20250309_50603730-9f69-4ed7-bccf-31c474f83e14.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 · 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
ndc (product): 55154-2334
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN50603730-9f69-4ed7-bccf-31c474f83e148
197944methocarbamol 750 MG Oral TabletPSN50603730-9f69-4ed7-bccf-31c474f83e148
197943methocarbamol 500 MG Oral TabletSCD50603730-9f69-4ed7-bccf-31c474f83e148
197944methocarbamol 750 MG Oral TabletSCD50603730-9f69-4ed7-bccf-31c474f83e148

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-2334-05515423340010 BLISTER PACK in 1 BAG (55154-2334-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2017-12-150000-00-00NoNoCurrent