Ultramicrosize Griseofulvin

Product NDC: 42794-014
11-digit product format: 427940014
Labeler code: 42794
Product ID: 42794-014_d58d8124-4925-b8a1-e053-2995a90ac4c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ultramicrosize Griseofulvin
Dosage form: TABLET
Route: ORAL
Labeler: Sigmapharm Laboratories, LLC
Application: ANDA202545
Marketing category: ANDA
Marketing start: 2012-11-15
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 42.

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
A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2012-10-22
A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB		2012-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202545-001	AB
A202545-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202545-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202545-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202545-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202545-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202545-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202545-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202545-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202545-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202545-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202545-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202545-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202545-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202545-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202545-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202545-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202545-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202545-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202545-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202545-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202545-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202545-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202545-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202545-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202545-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202545-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202545-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202545-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202545-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202545-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202545-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202545-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202545-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202545-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202545-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202545-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202545-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202545-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202545-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202545-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202545-002	AB	1	`bb7c543d1eb4…`

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
37b4d132-84f1-4394-b468-7e74eeec61eb	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
42794-014-08	Ultramicrosize Griseofulvin	30 in 1 BOTTLE	TABLET	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42794-014-08	EA - Each	42794-014	cc40fbc4-431a-44ad-ada0-8a9d3cd3cebc	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42794-014	ULTRAMICROSIZE GRISEOFULVIN TABLET [SIGMAPHARM LABORATORIES, LLC]	10	Current NDC, Legacy NDC, 1 package rows	20220115_37b4d132-84f1-4394-b468-7e74eeec61eb.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	Sigmapharm Laboratories, LLC	37b4d132-84f1-4394-b468-7e74eeec61eb	2022-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202545 application number: ANDA202545 ndc (product): 42794-014

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	37b4d132-84f1-4394-b468-7e74eeec61eb	10
239239	griseofulvin 250 MG Oral Tablet	PSN	37b4d132-84f1-4394-b468-7e74eeec61eb	10
242831	griseofulvin 125 MG Oral Tablet	SCD	37b4d132-84f1-4394-b468-7e74eeec61eb	10
239239	griseofulvin 250 MG Oral Tablet	SCD	37b4d132-84f1-4394-b468-7e74eeec61eb	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42794-014-08	42794001408	30 TABLET in 1 BOTTLE (42794-014-08)	30 tablet	2016-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ULTRAMICROSIZE GRISEOFULVIN TABLETS, USP 125 mg and 250 mg Rx Only	Sigmapharm Laboratories, LLC	2022-01-14	HUMAN PRESCRIPTION DRUG LABEL	10