Ultramicrosize Griseofulvin

Product NDC: 0781-5827
Requested package NDC: 0781-5827-01
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2018-12-26
A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB		2018-12-26

Therapeutic equivalence codes#

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

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

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202805-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202805-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202805-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202805-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202805-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202805-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202805-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202805-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202805-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202805-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202805-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202805-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202805-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202805-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202805-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202805-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202805-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202805-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202805-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202805-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202805-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202805-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202805-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202805-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202805-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202805-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202805-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202805-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202805-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202805-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202805-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202805-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202805-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202805-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202805-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202805-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202805-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202805-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202805-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202805-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ultramicrosize Griseofulvin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GRISEOFULVIN	125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
32HRV3E3D5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
50874f84-35e6-097e-94d8-7241c05d199f	Product name	2	20190416
024bc7a6-8e89-3d87-480f-f3ffc8f2ad80	Product name	1	20140508
0b9696ae-027f-1570-8c58-4178203eb52b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0781-5827-01	Ultramicrosize Griseofulvin	100 in 1 BOTTLE	TABLET, COATED	100		8
0781-5827-05	Ultramicrosize Griseofulvin	500 in 1 BOTTLE	TABLET, COATED	500		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5827-01	EA - Each	0781-5827	27809275-230f-4c1f-b4a9-9a16e4e00dd1	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-5827	ULTRAMICROSIZE GRISEOFULVIN TABLET, COATED [SANDOZ INC]	7	Current NDC, Legacy NDC, 2 package rows	20250328_f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultramicrosize Griseofulvin	ULTRAMICROSIZE GRISEOFULVIN	Sandoz Inc	f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd	2025-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202805 application number: ANDA202805 ndc (package): 0781-5827-01 ndc (product): 0781-5827 ndc11 (package): 00781582701

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
32HRV3E3D5	GRISEOFULVIN	126-07-8	GRISEOFULVIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
242831	griseofulvin 125 MG Oral Tablet	PSN	f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd	8
239239	griseofulvin 250 MG Oral Tablet	PSN	f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd	8
242831	griseofulvin 125 MG Oral Tablet	SCD	f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd	8
239239	griseofulvin 250 MG Oral Tablet	SCD	f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-5827-01	00781582701	100 TABLET, COATED in 1 BOTTLE (0781-5827-01)	2020-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ultramicrosize Griseofulvin Tablets Rx Only	Sandoz Inc	2025-05-14	HUMAN PRESCRIPTION DRUG LABEL	8