FDA.reportPublic FDA data

Methocarbamol

Product NDC
53002-3591
11-digit product format
530023591
Labeler code
53002
Product ID
53002-3591_b775ab12-cad1-4a56-9be8-3dff8b6e1b28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA209312
Marketing category
ANDA
Marketing start
2018-07-02
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
53002-3591-22025-01-30C16284748780-1f386c649-a06a-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
53002-3591-32025-01-30C16284748780-1f386c649-a06a-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
53002-3591-42025-01-30C16284748780-1f386c649-a06a-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
53002-3591-22023-06-07C16284748780-1f386c649-a06a-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
53002-3591-32023-06-07C16284748780-1f386c649-a06a-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
53002-3591-42023-06-07C16284748780-1f386c649-a06a-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
53002-3591-22023-01-30C16284748780-1f386c649-a06a-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
53002-3591-32023-01-30C16284748780-1f386c649-a06a-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only
53002-3591-42023-01-30C16284748780-1f386c649-a06a-0266-e053-dadaa90a7c1aMethocarbamol Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3591-2Methocarbamol20 in 1 BOTTLETABLET, COATED207
53002-3591-3Methocarbamol30 in 1 BOTTLETABLET, COATED307
53002-3591-4Methocarbamol40 in 1 BOTTLETABLET, COATED407

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3591METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [RPK PHARMACEUTICALS, INC.]7Legacy NDC, 3 package rows20230707_21e2c2ef-3fee-4029-8837-23a476fcad5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN21e2c2ef-3fee-4029-8837-23a476fcad5a7
197944methocarbamol 750 MG Oral TabletPSN21e2c2ef-3fee-4029-8837-23a476fcad5a7
197943methocarbamol 500 MG Oral TabletSCD21e2c2ef-3fee-4029-8837-23a476fcad5a7
197944methocarbamol 750 MG Oral TabletSCD21e2c2ef-3fee-4029-8837-23a476fcad5a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-3591-25300235910220 TABLET, COATED in 1 BOTTLE (53002-3591-2) 2019-01-010000-00-00NoNoCurrent
53002-3591-35300235910330 TABLET, COATED in 1 BOTTLE (53002-3591-3) 2019-01-010000-00-00NoNoCurrent
53002-3591-45300235910440 TABLET, COATED in 1 BOTTLE (53002-3591-4) 2019-01-010000-00-00NoNoCurrent