FDA.reportPublic FDA data

METHOCARBAMOL

Product NDC
61919-148
11-digit product format
619190148
Labeler code
61919
Product ID
61919-148_f2150aa9-99b9-0c64-e053-2a95a90a1fde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHOCARBAMOL
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA086988
Marketing category
ANDA
Marketing start
2016-03-22
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
2024-12-31
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
61919-148-302020-01-31C16284748780-19d75b9d0-fe53-f424-e053-dadaa90a57ceMethocarbamol
61919-148-402020-01-31C16284748780-19d75b9d0-fe53-f424-e053-dadaa90a57ceMethocarbamol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-148-30Methocarbamol30 in 1 BOTTLETABLET304
61919-148-40Methocarbamol40 in 1 BOTTLETABLET404
61919-148-60Methocarbamol60 in 1 BOTTLETABLET604
61919-148-90Methocarbamol90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-148-30EA - Each61919-14828d06cbb-6773-4ff4-81bc-c3c87df6a42612015-03-03
61919-148-60EA - Each61919-148cb314e47-6e8d-4e21-a858-6721715e0aab12014-10-03
61919-148-90EA - Each61919-1488f7fd00c-28af-48e6-af2e-0e11e9f9b79312015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOCARBAMOLACTIVE INGREDIENT125OD7737XMETHOCARBAMOL TABLET [DIRECT RX]4
METHOCARBAMOLACTIVE MOIETY125OD7737XMETHOCARBAMOL TABLET [DIRECT RX]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOCARBAMOL TABLET [DIRECT RX]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETHOCARBAMOL TABLET [DIRECT RX]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHOCARBAMOL TABLET [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-148METHOCARBAMOL TABLET, COATED METHOCARBAMOL TABLET [DIRECT RX]15Legacy NDC20240915_31508051-c9cb-149b-e054-00144ff88e88.zip
61919-148METHOCARBAMOL TABLET [DIRECT RX]4Legacy NDC, 4 package rows20151104_d3bf7987-13dc-49e0-961b-b881a906520a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSNd3bf7987-13dc-49e0-961b-b881a906520a4
197944methocarbamol 750 MG Oral TabletPSNd3bf7987-13dc-49e0-961b-b881a906520a4
197943methocarbamol 500 MG Oral TabletSCDd3bf7987-13dc-49e0-961b-b881a906520a4
197944methocarbamol 750 MG Oral TabletSCDd3bf7987-13dc-49e0-961b-b881a906520a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-148-306191901483030 in 1 BOTTLEHistorical
61919-148-406191901484040 in 1 BOTTLEHistorical
61919-148-606191901486060 in 1 BOTTLEHistorical
61919-148-7261919014872120 TABLET in 1 BOTTLE (61919-148-72) 120 tablet2016-03-220000-00-00NoNoCurrent
61919-148-906191901489090 in 1 BOTTLEHistorical