Ultramicrosize Griseofulvin

Product NDC: 0781-5828
Requested package NDC: 0781-5828-05
11-digit product format: 007815828
Labeler code: 0781
Product ID: 0781-5828_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: 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

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 2 · 60 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
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202805-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2018-12-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202805-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2018-12-26	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202805-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202805-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202805-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202805-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202805-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202805-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202805-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202805-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202805-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202805-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202805-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202805-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202805-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202805-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202805-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202805-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202805-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202805-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202805-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202805-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202805-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202805-002	AB	1	`a72a2bbeb626…`

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
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): 0781-5828-05 ndc (product): 0781-5828 ndc11 (package): 00781582805

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GRISEOFULVIN	250 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
0781-5828-01	Ultramicrosize Griseofulvin	100 in 1 BOTTLE	TABLET, COATED	100		8
0781-5828-05	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
0781-5828-01	EA - Each	0781-5828	cdb14a7b-9b1e-403b-97d5-32d51940ea23	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-5828	ULTRAMICROSIZE GRISEOFULVIN TABLET, COATED [SANDOZ INC]	7	Current NDC, Legacy NDC, 2 package rows	20250328_f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd.zip

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
0781-5828-05	00781582805	500 TABLET, COATED in 1 BOTTLE (0781-5828-05)	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