FDA.reportPublic FDA data

Methocarbamol Tablets, USP, 500 mg

Product NDC
63561-0173
11-digit product format
635610173
Labeler code
63561
Product ID
63561-0173_35c0e9af-ba8b-0416-e063-6294a90a87f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Granulation Technology, Inc.
Application
ANDA212623
Marketing category
ANDA
Marketing start
2025-06-10
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 Tablets, USP, 500 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197943, 197944

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
63561-0173-12025-02-07C16284748780-12cef2736-730a-d83d-e063-dadaa90ab31fMethocarbamol Tablets, USP, 500 mg and 750 mg
63561-0173-52025-02-07C16284748780-12cef2736-730a-d83d-e063-dadaa90ab31fMethocarbamol Tablets, USP, 500 mg and 750 mg
63561-0173-12025-01-30C16284748780-12cef2736-730a-d83d-e063-dadaa90ab31fMethocarbamol Tablets, USP, 500 mg and 750 mg
63561-0173-52025-01-30C16284748780-12cef2736-730a-d83d-e063-dadaa90ab31fMethocarbamol Tablets, USP, 500 mg and 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0173-1Methocarbamol Tablets, USP, 500 mg100 in 1 BOTTLETABLET, FILM COATED1003
63561-0173-5Methocarbamol Tablets, USP, 500 mg500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63561-0173-1EA - Each63561-017376bdd0f0-632b-40f3-b5cd-2ecc6a26c38512025-07-08
63561-0173-5EA - Each63561-0173fb8ff3aa-2870-4bf5-9bea-c1497dd022ae12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63561-0173METHOCARBAMOL TABLETS, USP, 500 MG (METHOCARBAMOL) TABLET, FILM COATED METHOCARBAMOL TABLETS, USP, 750 MG (METHOCARBAMOL) TABLET, FILM COATED [GRANULATION TECHNOLOGY, INC.]2Current NDC, 2 package rows20250210_70c5342c-9597-4fe6-863c-f8ae4adc063a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN6ca768bf-5095-4148-82d2-a0c2dec16d878
197943methocarbamol 500 MG Oral TabletSCD6ca768bf-5095-4148-82d2-a0c2dec16d878
197943methocarbamol 500 MG Oral TabletPSN6500c6eb-fa1e-46a5-839f-13047e107e974
197943methocarbamol 500 MG Oral TabletSCD6500c6eb-fa1e-46a5-839f-13047e107e974
197943methocarbamol 500 MG Oral TabletPSN70c5342c-9597-4fe6-863c-f8ae4adc063a3
197944methocarbamol 750 MG Oral TabletPSN70c5342c-9597-4fe6-863c-f8ae4adc063a3
197943methocarbamol 500 MG Oral TabletSCD70c5342c-9597-4fe6-863c-f8ae4adc063a3
197944methocarbamol 750 MG Oral TabletSCD70c5342c-9597-4fe6-863c-f8ae4adc063a3
197943methocarbamol 500 MG Oral TabletPSNdfb0e2ee-fd87-4100-9d44-f7a091e73a6c2
197943methocarbamol 500 MG Oral TabletSCDdfb0e2ee-fd87-4100-9d44-f7a091e73a6c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63561-0173-163561017301100 TABLET, FILM COATED in 1 BOTTLE (63561-0173-1) 2025-06-10NoNoHistorical
63561-0173-563561017305500 TABLET, FILM COATED in 1 BOTTLE (63561-0173-5) 2025-06-10NoNoHistorical