Ultramicrosize Griseofulvin

Product NDC
42794-014
11-digit product format
427940014
Labeler code
42794
Product ID
42794-014_d58d8124-4925-b8a1-e053-2995a90ac4c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ultramicrosize Griseofulvin
Dosage form
TABLET
Route
ORAL
Labeler
Sigmapharm Laboratories, LLC
Application
ANDA202545
Marketing category
ANDA
Marketing start
2012-11-15
Substance
GRISEOFULVIN
Active strength
250 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
Ultramicrosize Griseofulvin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GRISEOFULVIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii32HRV3E3D5
Rxcui239239, 242831

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
42794-014-08Ultramicrosize Griseofulvin30 in 1 BOTTLETABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42794-014-08EA - Each42794-014cc40fbc4-431a-44ad-ada0-8a9d3cd3cebc12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42794-014ULTRAMICROSIZE GRISEOFULVIN TABLET [SIGMAPHARM LABORATORIES, LLC]10Current NDC, Legacy NDC, 1 package rows20220115_37b4d132-84f1-4394-b468-7e74eeec61eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242831griseofulvin 125 MG Oral TabletPSN37b4d132-84f1-4394-b468-7e74eeec61eb10
239239griseofulvin 250 MG Oral TabletPSN37b4d132-84f1-4394-b468-7e74eeec61eb10
242831griseofulvin 125 MG Oral TabletSCD37b4d132-84f1-4394-b468-7e74eeec61eb10
239239griseofulvin 250 MG Oral TabletSCD37b4d132-84f1-4394-b468-7e74eeec61eb10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42794-014-084279400140830 TABLET in 1 BOTTLE (42794-014-08) 30 tablet2016-05-110000-00-00NoNoCurrent