FDA.reportPublic FDA data

Ultramicrosize Griseofulvin

Product NDC
0115-1725
11-digit product format
001151725
Labeler code
0115
Product ID
0115-1725_1987e911-c9f4-4425-9e48-3adc3a5f92f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ultramicrosize Griseofulvin Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA204371
Marketing category
ANDA
Marketing start
2014-09-29
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
50874f84-35e6-097e-94d8-7241c05d199fProduct name220190416
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
024bc7a6-8e89-3d87-480f-f3ffc8f2ad80Product name120140508
0b9696ae-027f-1570-8c58-4178203eb52bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-1725-012023-04-19C16284748780-1f386c649-dd3f-0266-e053-dadaa90a7c1aUltramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg Rx only
0115-1725-032023-04-19C16284748780-1f386c649-dd3f-0266-e053-dadaa90a7c1aUltramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg Rx only
0115-1725-012023-01-30C16284748780-1f386c649-dd3f-0266-e053-dadaa90a7c1aUltramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg Rx only
0115-1725-032023-01-30C16284748780-1f386c649-dd3f-0266-e053-dadaa90a7c1aUltramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1725-01Ultramicrosize Griseofulvin100 in 1 BOTTLE, PLASTICTABLET, COATED1007
0115-1725-03Ultramicrosize Griseofulvin1000 in 1 BOTTLE, PLASTICTABLET, COATED10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1725-01EA - Each0115-1725813e3384-8ffd-4a18-a58a-dfd81dd4e7f612018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1725ULTRAMICROSIZE GRISEOFULVIN (ULTRAMICROSIZE GRISEOFULVIN TABLETS) TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]6Current NDC, Legacy NDC, 2 package rows20250321_f21314eb-3581-4e06-9fe7-8239cc80ba11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242831griseofulvin 125 MG Oral TabletPSNf21314eb-3581-4e06-9fe7-8239cc80ba117
239239griseofulvin 250 MG Oral TabletPSNf21314eb-3581-4e06-9fe7-8239cc80ba117
242831griseofulvin 125 MG Oral TabletSCDf21314eb-3581-4e06-9fe7-8239cc80ba117
239239griseofulvin 250 MG Oral TabletSCDf21314eb-3581-4e06-9fe7-8239cc80ba117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1725-0100115172501100 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1725-01) 2014-09-290000-00-00NoNoCurrent
0115-1725-03001151725031000 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1725-03) 2014-09-290000-00-00NoNoCurrent