FDA.reportPublic FDA data

Methocarbamol

Product NDC
68387-340
11-digit product format
683870340
Labeler code
68387
Product ID
68387-340_164d7dfa-e10c-4ca9-863a-1837e73b6522
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA085159
Marketing category
ANDA
Marketing start
2007-07-25
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
E
Listing certified through
2017-12-31
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
68387-340-242019-10-21C16284748780-1956f9ecf-bb38-621f-e053-dbdaa90a74adMethocarbamol Tablets
68387-340-302019-10-21C16284748780-1956f9ecf-bb38-621f-e053-dbdaa90a74adMethocarbamol Tablets
68387-340-452019-10-21C16284748780-1956f9ecf-bb38-621f-e053-dbdaa90a74adMethocarbamol Tablets
68387-340-602019-10-21C16284748780-1956f9ecf-bb38-621f-e053-dbdaa90a74adMethocarbamol Tablets
68387-340-902019-10-21C16284748780-1956f9ecf-bb38-621f-e053-dbdaa90a74adMethocarbamol Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-340-24Methocarbamol240 in 1 BOTTLE, PLASTICTABLET2401
68387-340-30Methocarbamol30 in 1 BOTTLE, PLASTICTABLET301
68387-340-45Methocarbamol45 in 1 BOTTLE, PLASTICTABLET451
68387-340-60Methocarbamol60 in 1 BOTTLE, PLASTICTABLET601
68387-340-90Methocarbamol90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-340-24EA - Each68387-340aae6e59a-cdf0-4a85-8b1e-91bb1554b57112012-07-24
68387-340-30EA - Each68387-340233d9162-6131-4314-9d6f-8faa0c52cb7112012-07-24
68387-340-45EA - Each68387-34048fa1628-91d6-4b0a-8366-2c950e101f4512012-07-24
68387-340-60EA - Each68387-3400ae08f43-9eae-4e2e-9ece-0dfdc801249512012-07-24
68387-340-90EA - Each68387-340771b935c-d865-4eb9-a65b-24ad378fd60212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOCARBAMOLACTIVE INGREDIENT125OD7737XMETHOCARBAMOL TABLET [KELTMAN PHARMACEUTICALS INC.]1
METHOCARBAMOLACTIVE MOIETY125OD7737XMETHOCARBAMOL TABLET [KELTMAN PHARMACEUTICALS INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHOCARBAMOL TABLET [KELTMAN PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHOCARBAMOL TABLET [KELTMAN PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOCARBAMOL TABLET [KELTMAN PHARMACEUTICALS INC.]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JMETHOCARBAMOL TABLET [KELTMAN PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHOCARBAMOL TABLET [KELTMAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-340METHOCARBAMOL TABLET [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 5 package rows20100810_2bdfecbb-d305-4bed-94bf-5c392b07e210.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN2bdfecbb-d305-4bed-94bf-5c392b07e2101
197944methocarbamol 750 MG Oral TabletPSN2bdfecbb-d305-4bed-94bf-5c392b07e2101
197943methocarbamol 500 MG Oral TabletSCD2bdfecbb-d305-4bed-94bf-5c392b07e2101
197944methocarbamol 750 MG Oral TabletSCD2bdfecbb-d305-4bed-94bf-5c392b07e2101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-340-2468387034024240 in 1 BOTTLE, PLASTICHistorical
68387-340-306838703403030 in 1 BOTTLE, PLASTICHistorical
68387-340-456838703404545 in 1 BOTTLE, PLASTICHistorical
68387-340-606838703406060 in 1 BOTTLE, PLASTICHistorical
68387-340-906838703409090 in 1 BOTTLE, PLASTICHistorical