FDA.reportPublic FDA data

Griseofulvin

Product NDC
0472-0013
11-digit product format
004720013
Labeler code
0472
Product ID
0472-0013_ffdfb856-e4f1-41de-837b-a773b1f6eaf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Griseofulvin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA065394
Marketing category
ANDA
Marketing start
2007-07-26
Substance
GRISEOFULVIN
Active strength
125 mg/5mL
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
GRISEOFULVIN125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii32HRV3E3D5
Rxcui239238

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
0472-0013-04Griseofulvin120 mL in 1 BOTTLESUSPENSION12017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0013-04ML - Milliliter0472-00135a56a5f4-0426-4033-a352-138ca12960ba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GRISEOFULVINACTIVE INGREDIENT32HRV3E3D5GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
GRISEOFULVINACTIVE MOIETY32HRV3E3D5GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
SUCROSEINACTIVE INGREDIENTC151H8M554GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
WATERINACTIVE INGREDIENT059QF0KO0RGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
GRISEOFULVINACTIVE INGREDIENT32HRV3E3D5GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
GRISEOFULVINACTIVE MOIETY32HRV3E3D5GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0013GRISEOFULVIN SUSPENSION [ACTAVIS PHARMA, INC.]16Current NDC, Legacy NDC, 1 package rows20241228_af318d5d-cc39-4a63-a590-b87c50f2694f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239238griseofulvin 125 MG in 5 mL Oral SuspensionPSNaf318d5d-cc39-4a63-a590-b87c50f2694f17
239238griseofulvin 25 MG/ML Oral SuspensionSCDaf318d5d-cc39-4a63-a590-b87c50f2694f17
239238griseofulvin 125 MG per 5 ML Oral SuspensionSYaf318d5d-cc39-4a63-a590-b87c50f2694f17
239238griseofulvin 125 MG in 5 mL Oral SuspensionPSNf1153794-33ae-4e9d-8c80-d29e01f82d771
239238griseofulvin 25 MG/ML Oral SuspensionSCDf1153794-33ae-4e9d-8c80-d29e01f82d771
239238griseofulvin 125 MG per 5 ML Oral SuspensionSYf1153794-33ae-4e9d-8c80-d29e01f82d771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0013-0400472001304120 mL in 1 BOTTLE (0472-0013-04) 120 ml2007-07-260000-00-00NoNoCurrent