Griseofulvin

Product NDC
62135-968
11-digit product format
621350968
Labeler code
62135
Product ID
62135-968_2589e155-f098-67fc-e063-6294a90a20b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Griseofulvin (microsize)
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA065200
Marketing category
ANDA
Marketing start
2005-03-02
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
62135-968-41Griseofulvin120 mL in 1 BOTTLESUSPENSION1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-968-41ML - Milliliter62135-968dbaaec7f-b2a4-4e44-a07c-c452321221e612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-968GRISEOFULVIN (GRISEOFULVIN (MICROSIZE)) SUSPENSION [CHARTWELL RX, LLC.]3Current NDC, Legacy NDC, 1 package rows20241030_9f7e4ecf-f992-42c5-81ea-91e6587b22a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239238griseofulvin 125 MG in 5 mL Oral SuspensionPSN9f7e4ecf-f992-42c5-81ea-91e6587b22a53
239238griseofulvin 25 MG/ML Oral SuspensionSCD9f7e4ecf-f992-42c5-81ea-91e6587b22a53
239238griseofulvin 125 MG per 5 ML Oral SuspensionSY9f7e4ecf-f992-42c5-81ea-91e6587b22a53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-968-4162135096841120 mL in 1 BOTTLE (62135-968-41) 120 ml2021-08-260000-00-00NoNoCurrent