FDA.reportPublic FDA data

Methocarbamol

Product NDC
50090-3578
11-digit product format
500903578
Labeler code
50090
Product ID
50090-3578_a527bac5-ad4e-4c49-acda-a457ff2ca164
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208507
Marketing category
ANDA
Marketing start
2018-01-15
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
50090-3578-02025-06-09C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-12025-06-09C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-22025-06-09C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-32025-06-09C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-42025-06-09C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-52025-06-09C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-62025-06-09C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-72025-06-09C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-82025-06-09C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-92025-06-09C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-02024-01-30C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-12024-01-30C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-22024-01-30C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-32024-01-30C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-42024-01-30C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-52024-01-30C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-62024-01-30C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-72024-01-30C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-82024-01-30C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg
50090-3578-92024-01-30C16284748780-11030e365-60f8-111a-e063-dadaa90a10e2Methocarbamol Tablets USP, 500 mg and 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3578-0Methocarbamol40 in 1 BOTTLETABLET, FILM COATED4013
50090-3578-1Methocarbamol20 in 1 BOTTLETABLET, FILM COATED2013
50090-3578-2Methocarbamol80 in 1 BOTTLETABLET, FILM COATED8013
50090-3578-3Methocarbamol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6013
50090-3578-4Methocarbamol30 in 1 BOTTLETABLET, FILM COATED3013
50090-3578-5Methocarbamol14 in 1 BOTTLETABLET, FILM COATED1413
50090-3578-6Methocarbamol24 in 1 BOTTLETABLET, FILM COATED2413
50090-3578-7Methocarbamol100 in 1 BOTTLETABLET, FILM COATED10013
50090-3578-8Methocarbamol56 in 1 BOTTLETABLET, FILM COATED5613
50090-3578-9Methocarbamol4 in 1 BOTTLETABLET, FILM COATED413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3578-1EA - Each50090-357831a36f44-7aeb-412b-ab99-684db2b374d212021-11-09
50090-3578-3EA - Each50090-35782eda4e15-f189-4eca-8752-5d25722aeb6112021-11-09
50090-3578-4EA - Each50090-357866937d40-10e3-4677-94fd-3b56adc8d26f12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3578METHOCARBAMOL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 10 package rows20220208_9357672f-5d4d-40f5-a304-e0c34e174dc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN9357672f-5d4d-40f5-a304-e0c34e174dc313
197943methocarbamol 500 MG Oral TabletSCD9357672f-5d4d-40f5-a304-e0c34e174dc313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3578-05009035780040 TABLET, FILM COATED in 1 BOTTLE (50090-3578-0) 2022-02-060000-00-00NoNoCurrent
50090-3578-15009035780120 TABLET, FILM COATED in 1 BOTTLE (50090-3578-1) 2018-09-130000-00-00NoNoCurrent
50090-3578-25009035780280 TABLET, FILM COATED in 1 BOTTLE (50090-3578-2) 2022-02-060000-00-00NoNoCurrent
50090-3578-35009035780360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3578-3) 2018-01-150000-00-00NoNoCurrent
50090-3578-45009035780430 TABLET, FILM COATED in 1 BOTTLE (50090-3578-4) 2019-04-110000-00-00NoNoCurrent
50090-3578-55009035780514 TABLET, FILM COATED in 1 BOTTLE (50090-3578-5) 2019-08-160000-00-00NoNoCurrent
50090-3578-65009035780624 TABLET, FILM COATED in 1 BOTTLE (50090-3578-6) 2022-02-060000-00-00NoNoCurrent
50090-3578-750090357807100 TABLET, FILM COATED in 1 BOTTLE (50090-3578-7) 2022-02-060000-00-00NoNoCurrent
50090-3578-85009035780856 TABLET, FILM COATED in 1 BOTTLE (50090-3578-8) 2022-02-060000-00-00NoNoCurrent
50090-3578-9500903578094 TABLET, FILM COATED in 1 BOTTLE (50090-3578-9) 2022-02-060000-00-00NoNoCurrent