FDA.reportPublic FDA data

Methocarbamol

Product NDC
50090-3557
11-digit product format
500903557
Labeler code
50090
Product ID
50090-3557_1b946146-7b78-440a-82bb-02e57f000bd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209312
Marketing category
ANDA
Marketing start
2018-07-02
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
50090-3557-12025-07-23C16284748780-1f386c64a-3d37-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
50090-3557-32025-07-23C16284748780-1f386c64a-3d37-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
50090-3557-42025-07-23C16284748780-1f386c64a-3d37-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
50090-3557-52025-07-23C16284748780-1f386c64a-3d37-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
50090-3557-12023-01-30C16284748780-1f386c64a-3d37-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
50090-3557-32023-01-30C16284748780-1f386c64a-3d37-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
50090-3557-42023-01-30C16284748780-1f386c64a-3d37-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
50090-3557-52023-01-30C16284748780-1f386c64a-3d37-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3557-1Methocarbamol20 in 1 BOTTLETABLET, COATED2010
50090-3557-3Methocarbamol60 in 1 BOTTLE, PLASTICTABLET, COATED6010
50090-3557-4Methocarbamol30 in 1 BOTTLE, PLASTICTABLET, COATED3010
50090-3557-5Methocarbamol14 in 1 BOTTLE, PLASTICTABLET, COATED1410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3557METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 4 package rows20210417_5f746f0f-e884-46d9-a104-529293b0fb90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN5f746f0f-e884-46d9-a104-529293b0fb9010
197943methocarbamol 500 MG Oral TabletSCD5f746f0f-e884-46d9-a104-529293b0fb9010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3557-15009035570120 TABLET, COATED in 1 BOTTLE (50090-3557-1) 2018-08-270000-00-00NoNoCurrent
50090-3557-35009035570360 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-3557-3) 2018-07-020000-00-00NoNoCurrent
50090-3557-45009035570430 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-3557-4) 2018-07-020000-00-00NoNoCurrent
50090-3557-55009035570514 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-3557-5) 2018-07-020000-00-00NoNoCurrent