FDA.reportPublic FDA data

Ultramicrosize Griseofulvin

Product NDC
0781-5827
Requested package NDC
0781-5827-05
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202805-001GRISEOFULVIN, ULTRAMICROSIZEGRISEOFULVIN, ULTRAMICROSIZE125MGTABLET / ORALAB2018-12-26
A202805-002GRISEOFULVIN, ULTRAMICROSIZEGRISEOFULVIN, ULTRAMICROSIZE250MGTABLET / ORALAB2018-12-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202805-001AB
A202805-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202805-001GRISEOFULVIN, ULTRAMICROSIZE125MGTABLET / ORALAB2018-12-26a50c72e98297…
2026-08-01 22:54:322026-06A202805-002GRISEOFULVIN, ULTRAMICROSIZE250MGTABLET / ORALAB2018-12-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202805-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202805-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultramicrosize GriseofulvinULTRAMICROSIZE GRISEOFULVINSandoz Incf4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd2025-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202805
application number: ANDA202805
ndc (package): 0781-5827-05
ndc (product): 0781-5827
ndc11 (package): 00781582705

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
32HRV3E3D5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
239239Internal RxNorm lookup
242831Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebdAvailable on FDA.report

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
0781-5827-0500781582705500 TABLET, COATED in 1 BOTTLE (0781-5827-05) 2020-04-010000-00-00NoNoCurrent