FDA.reportPublic FDA data

Methocarbamol

Product NDC
50436-0123
11-digit product format
504360123
Labeler code
50436
Product ID
50436-0123_4e9524e3-43c0-49ef-a503-b116f84fbff1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
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
2022-12-31
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
50436-0123-12023-01-30C16284748780-1f386c649-b177-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP, 500 mg and 750 mg
50436-0123-22023-01-30C16284748780-1f386c649-b177-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP, 500 mg and 750 mg
50436-0123-32023-01-30C16284748780-1f386c649-b177-0266-e053-dadaa90a7c1aMethocarbamol Tablets USP, 500 mg and 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0123-1Methocarbamol30 in 1 BOTTLETABLET, FILM COATED302
50436-0123-2Methocarbamol60 in 1 BOTTLETABLET, FILM COATED602
50436-0123-3Methocarbamol90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0123-1EA - Each50436-012377080d8a-b3b9-438b-aa3b-ed96a21b568c12021-09-07
50436-0123-2EA - Each50436-0123f3360047-76e2-45e2-8b96-85d97661b72712021-10-08
50436-0123-3EA - Each50436-012388c585db-d38f-4495-9c99-f6b7f20eec8512021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0123METHOCARBAMOL TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 3 package rows20210822_10f701d6-d6ff-4462-8b0a-ac44e4a20489.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN10f701d6-d6ff-4462-8b0a-ac44e4a204892
197943methocarbamol 500 MG Oral TabletSCD10f701d6-d6ff-4462-8b0a-ac44e4a204892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0123-15043601230130 TABLET, FILM COATED in 1 BOTTLE (50436-0123-1) 2021-08-200000-00-00NoNoCurrent
50436-0123-25043601230260 TABLET, FILM COATED in 1 BOTTLE (50436-0123-2) 2021-08-200000-00-00NoNoCurrent
50436-0123-35043601230390 TABLET, FILM COATED in 1 BOTTLE (50436-0123-3) 2021-08-200000-00-00NoNoCurrent