Ultramicrosize Griseofulvin

Product NDC
0781-5827
11-digit product format
007815827
Labeler code
0781
Product ID
0781-5827_6d66c19d-0069-4a47-a45c-567aa0398135
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ultramicrosize Griseofulvin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA202805
Marketing category
ANDA
Marketing start
2020-04-01
Substance
GRISEOFULVIN
Active strength
125 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
GRISEOFULVIN125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii32HRV3E3D5
Rxcui239239, 242831

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
0781-5827-01Ultramicrosize Griseofulvin100 in 1 BOTTLETABLET, COATED1008
0781-5827-05Ultramicrosize Griseofulvin500 in 1 BOTTLETABLET, COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5827-01EA - Each0781-582727809275-230f-4c1f-b4a9-9a16e4e00dd112020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5827ULTRAMICROSIZE GRISEOFULVIN TABLET, COATED [SANDOZ INC]7Current NDC, Legacy NDC, 2 package rows20250328_f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242831griseofulvin 125 MG Oral TabletPSNf4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd8
239239griseofulvin 250 MG Oral TabletPSNf4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd8
242831griseofulvin 125 MG Oral TabletSCDf4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd8
239239griseofulvin 250 MG Oral TabletSCDf4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5827-0100781582701100 TABLET, COATED in 1 BOTTLE (0781-5827-01) 2020-04-010000-00-00NoNoCurrent
0781-5827-0500781582705500 TABLET, COATED in 1 BOTTLE (0781-5827-05) 2020-04-010000-00-00NoNoCurrent