FDA.reportPublic FDA data

Methocarbamol

Product NDC
50436-4027
11-digit product format
504364027
Labeler code
50436
Product ID
50436-4027_6e78af02-9df2-4e69-8b6b-b579aecb8a7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA085159
Marketing category
ANDA
Marketing start
2000-01-01
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
2020-12-31
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
50436-4027-12021-01-29C16284748780-1ba0f9c33-4f5b-a910-e053-dadaa90a0b85Methocarbamol Tablets
50436-4027-22021-01-29C16284748780-1ba0f9c33-4f5b-a910-e053-dadaa90a0b85Methocarbamol Tablets
50436-4027-32021-01-29C16284748780-1ba0f9c33-4f5b-a910-e053-dadaa90a0b85Methocarbamol Tablets
50436-4027-42021-01-29C16284748780-1ba0f9c33-4f5b-a910-e053-dadaa90a0b85Methocarbamol Tablets
50436-4027-52021-01-29C16284748780-1ba0f9c33-4f5b-a910-e053-dadaa90a0b85Methocarbamol Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4027-1Methocarbamol30 in 1 BOTTLETABLET3011
50436-4027-2Methocarbamol60 in 1 BOTTLETABLET6011
50436-4027-3Methocarbamol90 in 1 BOTTLETABLET9011
50436-4027-4Methocarbamol45 in 1 BOTTLETABLET4511
50436-4027-5Methocarbamol120 in 1 BOTTLETABLET12011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4027-1EA - Each50436-40270a6fa5bd-f5c2-40fd-82c6-f2418768b0e512013-02-13
50436-4027-2EA - Each50436-40272b996153-9822-4fe5-96ba-45f7cafb92ae12013-02-13
50436-4027-3EA - Each50436-402773333dd3-4e28-4953-8014-fadb845724d212013-10-17
50436-4027-4EA - Each50436-4027f20b1ac7-9612-42e7-8bc5-fb4637c85fff12013-02-13
50436-4027-5EA - Each50436-40273b830d21-d34f-4d1e-a0af-382c3e15621412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOCARBAMOLACTIVE INGREDIENT125OD7737XMETHOCARBAMOL TABLET [UNIT DOSE SERVICES]3
METHOCARBAMOLACTIVE MOIETY125OD7737XMETHOCARBAMOL TABLET [UNIT DOSE SERVICES]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHOCARBAMOL TABLET [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOCARBAMOL TABLET [UNIT DOSE SERVICES]3
METHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT4GFU244C4JMETHOCARBAMOL TABLET [UNIT DOSE SERVICES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHOCARBAMOL TABLET [UNIT DOSE SERVICES]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHOCARBAMOL TABLET [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4027METHOCARBAMOL TABLET [UNIT DOSE SERVICES]11Legacy NDC, 5 package rows20190504_82fa1561-bd05-4e40-91cc-290505a36750.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN82fa1561-bd05-4e40-91cc-290505a3675011
197944methocarbamol 750 MG Oral TabletSCD82fa1561-bd05-4e40-91cc-290505a3675011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4027-15043640270130 in 1 BOTTLEHistorical
50436-4027-25043640270260 in 1 BOTTLEHistorical
50436-4027-35043640270390 in 1 BOTTLEHistorical
50436-4027-45043640270445 in 1 BOTTLEHistorical
50436-4027-550436402705120 in 1 BOTTLEHistorical