FDA.reportPublic FDA data

Griseofulviin (microsize)

Product NDC
42254-306
11-digit product format
422540306
Labeler code
42254
Product ID
42254-306_f1153794-33ae-4e9d-8c80-d29e01f82d77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Griseofulvin (microsize)
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA065394
Marketing category
ANDA
Marketing start
2007-07-26
Marketing end
0000-00-00
Substance
GRISEOFULVIN
Active strength
125 mg/5mL
Pharmacologic classes
Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [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
50874f84-35e6-097e-94d8-7241c05d199fProduct name220190416
024bc7a6-8e89-3d87-480f-f3ffc8f2ad80Product name120140508
0b9696ae-027f-1570-8c58-4178203eb52bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-306-042019-09-24C16284748780-19350213a-3d22-c013-e053-90daa90a1393GRISEOFULVIN ORAL SUSPENSION (microsize) USP, 125 mg/5 mL Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-306-04Griseofulviin (microsize)120 mL in 1 BOTTLESUSPENSION1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-306-04ML - Milliliter42254-30693b80ded-fc2a-4648-8e4c-511b7328605112013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
42254-306GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20130221_f1153794-33ae-4e9d-8c80-d29e01f82d77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsStatus
42254-306-0442254030604120 mL in 1 BOTTLE120 mlHistorical