FDA.reportPublic FDA data

Methocarbamol

Product NDC
53002-3041
11-digit product format
530023041
Labeler code
53002
Product ID
53002-3041_544b6a7b-9b53-42e4-ad9d-9de77edf5700
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA208507
Marketing category
ANDA
Marketing start
2018-01-15
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
53002-3041-12025-01-30C16284748780-12cef2736-66b5-d83d-e063-dadaa90ab31fMethocarbamol Tablets USP, 500 mg and 750 mg
53002-3041-22025-01-30C16284748780-12cef2736-66b5-d83d-e063-dadaa90ab31fMethocarbamol Tablets USP, 500 mg and 750 mg
53002-3041-32025-01-30C16284748780-12cef2736-66b5-d83d-e063-dadaa90ab31fMethocarbamol Tablets USP, 500 mg and 750 mg
53002-3041-62025-01-30C16284748780-12cef2736-66b5-d83d-e063-dadaa90ab31fMethocarbamol Tablets USP, 500 mg and 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3041-1Methocarbamol10 in 1 BOTTLETABLET, FILM COATED101
53002-3041-2Methocarbamol20 in 1 BOTTLETABLET, FILM COATED201
53002-3041-3Methocarbamol30 in 1 BOTTLETABLET, FILM COATED301
53002-3041-6Methocarbamol60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3041METHOCARBAMOL TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 4 package rows20220331_ce5baf7c-2e42-4c1a-a132-a7cf40e5c68a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSNce5baf7c-2e42-4c1a-a132-a7cf40e5c68a1
197943methocarbamol 500 MG Oral TabletSCDce5baf7c-2e42-4c1a-a132-a7cf40e5c68a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-3041-15300230410110 TABLET, FILM COATED in 1 BOTTLE (53002-3041-1) 2022-07-010000-00-00NoNoCurrent
53002-3041-25300230410220 TABLET, FILM COATED in 1 BOTTLE (53002-3041-2) 2022-07-010000-00-00NoNoCurrent
53002-3041-35300230410330 TABLET, FILM COATED in 1 BOTTLE (53002-3041-3) 2022-07-010000-00-00NoNoCurrent
53002-3041-65300230410660 TABLET, FILM COATED in 1 BOTTLE (53002-3041-6) 2022-07-010000-00-00NoNoCurrent