Ultramicrosize Griseofulvin

Product NDC: 0115-1724
11-digit product format: 001151724
Labeler code: 0115
Product ID: 0115-1724_1987e911-c9f4-4425-9e48-3adc3a5f92f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ultramicrosize Griseofulvin Tablets
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA204371
Marketing category: ANDA
Marketing start: 2014-09-29
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
A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09
A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204371-001	AB
A204371-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB		2014-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204371-001	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2014-01-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204371-002	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RS	2014-01-09	`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	A204371-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204371-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204371-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204371-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204371-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204371-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204371-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204371-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204371-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204371-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204371-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204371-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204371-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204371-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204371-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204371-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204371-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204371-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204371-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204371-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204371-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204371-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204371-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204371-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204371-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204371-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204371-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204371-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204371-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204371-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204371-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204371-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204371-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204371-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204371-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204371-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204371-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204371-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204371-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204371-002	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
f21314eb-3581-4e06-9fe7-8239cc80ba11	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
50874f84-35e6-097e-94d8-7241c05d199f	Product name	2	20190416
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
024bc7a6-8e89-3d87-480f-f3ffc8f2ad80	Product name	1	20140508
0b9696ae-027f-1570-8c58-4178203eb52b	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0115-1724-01	2023-04-19	Ultramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg Rx only
0115-1724-02	2023-04-19	Ultramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg Rx only
0115-1724-01	2023-01-30	Ultramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg Rx only
0115-1724-02	2023-01-30	Ultramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0115-1724-01	Ultramicrosize Griseofulvin	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100		7
0115-1724-02	Ultramicrosize Griseofulvin	500 in 1 BOTTLE, PLASTIC	TABLET, COATED	500		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1724-01	EA - Each	0115-1724	140b94b7-6e29-4ff6-88b2-3c952f10c0d0	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1724	ULTRAMICROSIZE GRISEOFULVIN (ULTRAMICROSIZE GRISEOFULVIN TABLETS) TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	6	Current NDC, Legacy NDC, 2 package rows	20250321_f21314eb-3581-4e06-9fe7-8239cc80ba11.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 TABLETS	Amneal Pharmaceuticals of New York LLC	f21314eb-3581-4e06-9fe7-8239cc80ba11	2025-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204371 application number: ANDA204371 ndc (product): 0115-1724

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	f21314eb-3581-4e06-9fe7-8239cc80ba11	7
239239	griseofulvin 250 MG Oral Tablet	PSN	f21314eb-3581-4e06-9fe7-8239cc80ba11	7
242831	griseofulvin 125 MG Oral Tablet	SCD	f21314eb-3581-4e06-9fe7-8239cc80ba11	7
239239	griseofulvin 250 MG Oral Tablet	SCD	f21314eb-3581-4e06-9fe7-8239cc80ba11	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1724-01	00115172401	100 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1724-01)	2014-09-29	0000-00-00	No	No	Current
0115-1724-02	00115172402	500 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1724-02)	2014-09-29	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	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals Private Limited \| ANI Pharmaceuticals, Inc.	2025-12-20	HUMAN PRESCRIPTION DRUG LABEL	7