FDA.reportPublic FDA data

Methocarbamol

Product NDC
50090-5008
11-digit product format
500905008
Labeler code
50090
Product ID
50090-5008_71058c3d-80fe-471d-a6b6-f3fa9215dfa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

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 Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197944

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5008-02023-02-07C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-12023-02-07C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-22023-02-07C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-32023-02-07C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-42023-02-07C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-62023-02-07C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-72023-02-07C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-02023-01-30C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-12023-01-30C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-22023-01-30C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-32023-01-30C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-42023-01-30C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-62023-01-30C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-72023-01-30C16284748780-1f386c64a-0ef5-0266-e053-dadaa90a7c1aMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5008-0Methocarbamol20 in 1 BOTTLETABLET205
50090-5008-1Methocarbamol40 in 1 BOTTLETABLET405
50090-5008-2Methocarbamol28 in 1 BOTTLETABLET285
50090-5008-3Methocarbamol30 in 1 BOTTLETABLET305
50090-5008-4Methocarbamol60 in 1 BOTTLETABLET605
50090-5008-6Methocarbamol100 in 1 BOTTLETABLET1005
50090-5008-7Methocarbamol12 in 1 BOTTLETABLET125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5008-0EA - Each50090-5008eb1bbf65-7854-482a-a984-f2b6f7609ae412022-12-07
50090-5008-1EA - Each50090-5008f9a412ac-aaf1-40c6-99fd-19eecbace9ef12022-12-07
50090-5008-2EA - Each50090-50083ed133e9-08ae-4d67-b493-aee3e7fc38e412022-12-07
50090-5008-3EA - Each50090-5008bff20f9f-2710-4d58-b5ab-6da456ee4af612021-08-05
50090-5008-4EA - Each50090-50082668e42b-6841-43a3-b26a-a267191f638d12022-12-07
50090-5008-6EA - Each50090-5008f8dea446-4570-4e5c-a7e2-3881816b574b12022-12-07
50090-5008-7EA - Each50090-5008be173c78-6476-40ee-b001-a11737a1e12712022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5008METHOCARBAMOL TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 7 package rows20230208_d217bd1d-0b6e-4a4c-a47b-de73b94e8b13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSNd217bd1d-0b6e-4a4c-a47b-de73b94e8b135
197944methocarbamol 750 MG Oral TabletSCDd217bd1d-0b6e-4a4c-a47b-de73b94e8b135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5008-05009050080020 TABLET in 1 BOTTLE (50090-5008-0) 20 tablet2020-04-150000-00-00NoNoCurrent
50090-5008-15009050080140 TABLET in 1 BOTTLE (50090-5008-1) 40 tablet2020-04-150000-00-00NoNoCurrent
50090-5008-25009050080228 TABLET in 1 BOTTLE (50090-5008-2) 28 tablet2020-04-150000-00-00NoNoCurrent
50090-5008-35009050080330 TABLET in 1 BOTTLE (50090-5008-3) 30 tablet2020-04-150000-00-00NoNoCurrent
50090-5008-45009050080460 TABLET in 1 BOTTLE (50090-5008-4) 60 tablet2020-04-150000-00-00NoNoCurrent
50090-5008-650090500806100 TABLET in 1 BOTTLE (50090-5008-6) 100 tablet2020-04-150000-00-00NoNoCurrent
50090-5008-75009050080712 TABLET in 1 BOTTLE (50090-5008-7) 12 tablet2020-04-150000-00-00NoNoCurrent