Griseofulvin

Product NDC
0781-5515
11-digit product format
007815515
Labeler code
0781
Product ID
0781-5515_79afc7a7-d77e-48eb-b1c6-6ea974801f38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Griseofulvin
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA091592
Marketing category
ANDA
Marketing start
2013-08-07
Substance
GRISEOFULVIN
Active strength
500 mg/1
Pharmacologic classes
Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Griseofulvin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GRISEOFULVIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii32HRV3E3D5
Rxcui239239, 310600

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
50874f84-35e6-097e-94d8-7241c05d199fProduct name220190416
024bc7a6-8e89-3d87-480f-f3ffc8f2ad80Product name120140508
0b9696ae-027f-1570-8c58-4178203eb52bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-5515-01Griseofulvin100 in 1 BOTTLETABLET1004
0781-5515-05Griseofulvin500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5515-01EA - Each0781-55157c5cfca1-f8c5-4433-90bd-bb6d691fcd9212013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GRISEOFULVINACTIVE INGREDIENT32HRV3E3D5GRISEOFULVIN TABLET [SANDOZ INC]1
GRISEOFULVINACTIVE MOIETY32HRV3E3D5GRISEOFULVIN TABLET [SANDOZ INC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JGRISEOFULVIN TABLET [SANDOZ INC]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGRISEOFULVIN TABLET [SANDOZ INC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGRISEOFULVIN TABLET [SANDOZ INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GRISEOFULVIN TABLET [SANDOZ INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GRISEOFULVIN TABLET [SANDOZ INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGRISEOFULVIN TABLET [SANDOZ INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5515GRISEOFULVIN TABLET [SANDOZ INC]3Current NDC, Legacy NDC, 2 package rows20191122_98829d90-b289-4bec-a625-7af412a5cb2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239239griseofulvin 250 MG Oral TabletPSN98829d90-b289-4bec-a625-7af412a5cb2d4
310600griseofulvin 500 MG Oral TabletPSN98829d90-b289-4bec-a625-7af412a5cb2d4
239239griseofulvin 250 MG Oral TabletSCD98829d90-b289-4bec-a625-7af412a5cb2d4
310600griseofulvin 500 MG Oral TabletSCD98829d90-b289-4bec-a625-7af412a5cb2d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5515-0100781551501100 TABLET in 1 BOTTLE (0781-5515-01) 100 tablet2013-08-070000-00-00NoNoCurrent
0781-5515-0500781551505500 TABLET in 1 BOTTLE (0781-5515-05) 500 tablet2013-08-070000-00-00NoNoCurrent