FDA.reportPublic FDA data

Methocarbamol

Product NDC
50090-0183
11-digit product format
500900183
Labeler code
50090
Product ID
50090-0183_24d79966-8b82-4c96-bb66-c52251c56843
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
500 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
METHOCARBAMOL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197943

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
50090-0183-02023-12-27C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only
50090-0183-02023-12-27C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only
50090-0183-22023-12-27C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only
50090-0183-22023-12-27C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only
50090-0183-42023-12-27C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only
50090-0183-42023-12-27C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only
50090-0183-02023-01-30C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only
50090-0183-02023-01-30C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only
50090-0183-22023-01-30C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only
50090-0183-22023-01-30C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only
50090-0183-42023-01-30C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only
50090-0183-42023-01-30C16284748780-1f386c64a-3973-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0183-0Methocarbamol10 in 1 BOTTLETABLET1014
50090-0183-2Methocarbamol7 in 1 BOTTLETABLET714
50090-0183-4Methocarbamol90 in 1 BOTTLETABLET9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0183METHOCARBAMOL TABLET [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 3 package rows20231227_069045f1-d699-41d0-b674-cdb71cd5fbd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN069045f1-d699-41d0-b674-cdb71cd5fbd014
197943methocarbamol 500 MG Oral TabletSCD069045f1-d699-41d0-b674-cdb71cd5fbd014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0183-05009001830010 TABLET in 1 BOTTLE (50090-0183-0) 10 tablet2016-06-210000-00-00NoNoCurrent
50090-0183-2500900183027 TABLET in 1 BOTTLE (50090-0183-2) 7 tablet2014-11-280000-00-00NoNoCurrent
50090-0183-45009001830490 TABLET in 1 BOTTLE (50090-0183-4) 90 tablet2014-11-280000-00-00NoNoCurrent