Methocarbamol

Product NDC
51655-574
Requested package NDC
51655-574-52
11-digit product format
516550574
Labeler code
51655
Product ID
51655-574_494e36ce-4cbb-e470-e063-6394a90a2955
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090200
Marketing category
ANDA
Marketing start
2020-09-16
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
A090200-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2009-11-06
A090200-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2009-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090200-001AA
A090200-002AA

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 UTC2026-02A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06782e0a99824c…

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 UTC2026-02A090200-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090200-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090200-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090200-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090200-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090200-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090200-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090200-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090200-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090200-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090200-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090200-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090200-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090200-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090200-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090200-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090200-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090200-002AA1782e0a99824c…

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f31ccb09-7a9a-60af-e053-2995a90a6e97Available 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
51655-574-52Methocarbamol30 in 1 BOTTLE, PLASTICTABLET302
51655-574-84Methocarbamol14 in 1 BOTTLE, PLASTICTABLET142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-574METHOCARBAMOL TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20230407_f31ccb09-7a9a-60af-e053-2995a90a6e97.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLAmerican Health Packagingd842fe4e-fc46-4d70-9ca3-b47191672f962026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLUnit Dose Solutions, Inc.5539d4f6-1192-2770-e063-6394a90a1e502026-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
METHOCARBAMOLMETHOCARBAMOLDIRECT RX31508051-c9cb-149b-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAvPAKbe37bc85-6a41-00d8-e053-2a95a90ae5042026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNorthwind Health Company, LLCf31ccb09-7a9a-60af-e053-2995a90a6e972026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
ndc (package): 51655-574-52
ndc (product): 51655-574
ndc11 (package): 51655057452
MethocarbamolMETHOCARBAMOLNorthwind Health Company, LLCdf63611f-90e4-6bbe-e053-2a95a90a2aad2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC18810520-3040-4802-e063-6294a90a1ec02025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLCardinal Health 107, LLC05b287d3-5004-4d8b-9ebe-a96caa2b8d892025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutions9aed8304-fa4e-49d6-bd81-fcb3e4cc61732025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutionsff55df39-e314-4120-8fab-3757cbe5a8722025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutions069045f1-d699-41d0-b674-cdb71cd5fbd02025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.eed9ebd1-c243-4e82-bf4e-5fec370e722e2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLCoupler LLC2cee3893-70b7-6c2c-e063-6394a90aa79a2025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCf4e98f9f-b20b-8608-e053-2a95a90aa6b02024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f47c39b-9373-454f-9a4e-ba6dd65dd7a42024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackadd9e47f-11ac-e10d-bfc2-b9c52aa08fa52024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals,Inc.9d6024b2-ee1a-3a79-e053-2a95a90a1bf42024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals, Inc.3e89a426-c741-2f44-e054-00144ff8d46c2024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC1880efb2-b97e-1e4d-e063-6294a90ab3e32024-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLXLCare Pharmaceuticals Inc.f8bfb5cb-b7d0-4e09-b6bd-97a51d82c9912024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSNf31ccb09-7a9a-60af-e053-2995a90a6e972
197943methocarbamol 500 MG Oral TabletSCDf31ccb09-7a9a-60af-e053-2995a90a6e972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-574-525165505745230 TABLET in 1 BOTTLE, PLASTIC (51655-574-52) 30 tablet2020-12-23NoNoCurrent