FDA.reportPublic FDA data

Methocarbamol

Product NDC
50090-1781
11-digit product format
500901781
Labeler code
50090
Product ID
50090-1781_ee81560c-8542-4384-ae20-9c7ab551c957
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090200
Marketing category
ANDA
Marketing start
2013-03-20
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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06c2088c7a36db…
2026-10-15 13:18:302026-09A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06c2088c7a36db…
2026-09-14 22:38:342026-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0684e616aacf4f…
2026-09-14 22:38:342026-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0684e616aacf4f…
2026-08-18 06:07:402026-07A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A090200-001AA1c2088c7a36db…
2026-10-15 13:18:302026-09A090200-002AA1c2088c7a36db…
2026-09-14 22:38:342026-08A090200-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A090200-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A090200-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A090200-002AA1caaa826d4ba7…
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…

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 · 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
2c1f5949-d771-45c6-8d8a-5e1942c853dcAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-1781-02023-02-07Methocarbamol Tablets USP Rx Only
50090-1781-12023-02-07Methocarbamol Tablets USP Rx Only
50090-1781-22023-02-07Methocarbamol Tablets USP Rx Only
50090-1781-32023-02-07Methocarbamol Tablets USP Rx Only
50090-1781-42023-02-07Methocarbamol Tablets USP Rx Only
50090-1781-62023-02-07Methocarbamol Tablets USP Rx Only
50090-1781-72023-02-07Methocarbamol Tablets USP Rx Only
50090-1781-02023-01-30Methocarbamol Tablets USP Rx Only
50090-1781-12023-01-30Methocarbamol Tablets USP Rx Only
50090-1781-22023-01-30Methocarbamol Tablets USP Rx Only
50090-1781-32023-01-30Methocarbamol Tablets USP Rx Only
50090-1781-42023-01-30Methocarbamol Tablets USP Rx Only
50090-1781-62023-01-30Methocarbamol Tablets USP Rx Only
50090-1781-72023-01-30Methocarbamol Tablets USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1781-0Methocarbamol20 in 1 BOTTLETABLET2014
50090-1781-1Methocarbamol40 in 1 BOTTLETABLET4014
50090-1781-2Methocarbamol28 in 1 BOTTLETABLET2814
50090-1781-3Methocarbamol30 in 1 BOTTLETABLET3014
50090-1781-4Methocarbamol60 in 1 BOTTLETABLET6014
50090-1781-6Methocarbamol100 in 1 BOTTLETABLET10014
50090-1781-7Methocarbamol12 in 1 BOTTLETABLET1214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1781-0EA - Each50090-1781f4c221c0-4c8e-4bc9-8ff6-a9c0b0b6110c12021-09-07
50090-1781-1EA - Each50090-17812105860e-520f-4e19-80d1-ea6770c7d65412021-09-07
50090-1781-2EA - Each50090-1781c2e392e2-d411-4ed8-9a00-9d555dc2869712021-09-07
50090-1781-3EA - Each50090-17817d2be736-8e7a-4c45-a514-f785ffceced912021-08-05
50090-1781-4EA - Each50090-1781a957e9e2-e5c9-4c87-80bc-c88ca6d0e78412021-09-07
50090-1781-6EA - Each50090-1781ff36e59f-6821-4f75-8775-7adc05f6420112021-09-07
50090-1781-7EA - Each50090-1781254281c8-beb4-4937-95ff-86cff2b5ba3812021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1781METHOCARBAMOL TABLET [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 7 package rows20240106_2c1f5949-d771-45c6-8d8a-5e1942c853dc.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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLXLCare Pharmaceuticals Inc.f8bfb5cb-b7d0-4e09-b6bd-97a51d82c9912024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutions2c1f5949-d771-45c6-8d8a-5e1942c853dc2024-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
ndc (product): 50090-1781
MethocarbamolMETHOCARBAMOLProficient Rx LP10ae354f-94a4-4d4e-bccc-ea189726b7ce2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLCamber Pharmaceuticals, Inc.43af0c41-9990-4902-9384-75de5ea082832021-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN2c1f5949-d771-45c6-8d8a-5e1942c853dc14
197944methocarbamol 750 MG Oral TabletSCD2c1f5949-d771-45c6-8d8a-5e1942c853dc14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1781-05009017810020 TABLET in 1 BOTTLE (50090-1781-0) 20 tablet2015-04-160000-00-00NoNoCurrent
50090-1781-15009017810140 TABLET in 1 BOTTLE (50090-1781-1) 40 tablet2015-04-160000-00-00NoNoCurrent
50090-1781-25009017810228 TABLET in 1 BOTTLE (50090-1781-2) 28 tablet2015-04-160000-00-00NoNoCurrent
50090-1781-35009017810330 TABLET in 1 BOTTLE (50090-1781-3) 30 tablet2015-04-160000-00-00NoNoCurrent
50090-1781-45009017810460 TABLET in 1 BOTTLE (50090-1781-4) 60 tablet2015-04-160000-00-00NoNoCurrent
50090-1781-650090178106100 TABLET in 1 BOTTLE (50090-1781-6) 100 tablet2020-03-020000-00-00NoNoCurrent
50090-1781-75009017810712 TABLET in 1 BOTTLE (50090-1781-7) 12 tablet2015-04-160000-00-00NoNoCurrent