Griseofulvin

Product NDC
42794-012
11-digit product format
427940012
Labeler code
42794
Product ID
42794-012_e8a91e6c-8bed-66f5-e053-2a95a90aa489
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Griseofulvin
Dosage form
TABLET
Route
ORAL
Labeler
Sigmapharm Laboratories, LLC
Application
ANDA202482
Marketing category
ANDA
Marketing start
2012-12-06
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
Rxcui310600

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
42794-012-08Griseofulvin30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42794-012-08EA - Each42794-012777afe5e-40fe-4e46-90a8-62cae02afcd712020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42794-012GRISEOFULVIN TABLET [SIGMAPHARM LABORATORIES, LLC]2Current NDC, Legacy NDC, 1 package rows20220916_5bafb97f-621b-4b96-a787-68e0bb5c8637.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310600griseofulvin 500 MG Oral TabletPSN5bafb97f-621b-4b96-a787-68e0bb5c86372
310600griseofulvin 500 MG Oral TabletSCD5bafb97f-621b-4b96-a787-68e0bb5c86372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42794-012-084279400120830 TABLET in 1 BOTTLE (42794-012-08) 30 tablet2016-07-010000-00-00NoNoCurrent