Methocarbamol

Product NDC
21695-078
11-digit product format
216950078
Labeler code
21695
Product ID
21695-078_2e5d447c-a50c-4905-b56f-32fe86824dd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA085159
Marketing category
ANDA
Marketing start
2000-01-01
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-078-07Methocarbamol7 in 1 BOTTLETABLET73
21695-078-14Methocarbamol14 in 1 BOTTLETABLET143
21695-078-20Methocarbamol20 in 1 BOTTLETABLET203
21695-078-30Methocarbamol30 in 1 BOTTLETABLET303
21695-078-40Methocarbamol40 in 1 BOTTLETABLET403
21695-078-60Methocarbamol60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-078-07EA - Each21695-07811abd0a4-d903-4781-bdd4-9836bc45831312012-07-24
21695-078-14EA - Each21695-07890b8aefb-f014-4e64-ac98-d6095b9e11a212012-07-24
21695-078-20EA - Each21695-0784cc21192-bb11-421e-8aee-ac3af651e50112012-07-24
21695-078-30EA - Each21695-078c36e4d75-c459-41ec-bc0c-7cc9700bd25612012-07-24
21695-078-40EA - Each21695-0785bd89e21-541e-48a9-afd6-e5fecdf3f95812012-07-24
21695-078-60EA - Each21695-0782a584995-7626-4e4d-a2ac-eef9abd29ceb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOCARBAMOLACTIVE INGREDIENT125OD7737XMETHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
METHOCARBAMOLACTIVE MOIETY125OD7737XMETHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JMETHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-078METHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3Legacy NDC, 6 package rows20110721_41a6a652-046e-4780-9c6b-000363def056.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN41a6a652-046e-4780-9c6b-000363def0563
197944methocarbamol 750 MG Oral TabletPSN41a6a652-046e-4780-9c6b-000363def0563
197943methocarbamol 500 MG Oral TabletSCD41a6a652-046e-4780-9c6b-000363def0563
197944methocarbamol 750 MG Oral TabletSCD41a6a652-046e-4780-9c6b-000363def0563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-078-07216950078077 in 1 BOTTLEHistorical
21695-078-142169500781414 in 1 BOTTLEHistorical
21695-078-202169500782020 in 1 BOTTLEHistorical
21695-078-302169500783030 in 1 BOTTLEHistorical
21695-078-402169500784040 in 1 BOTTLEHistorical
21695-078-602169500786060 in 1 BOTTLEHistorical