Ketoconazole

Product NDC: 69292-224
11-digit product format: 692920224
Labeler code: 69292
Product ID: 69292-224_82cd25ed-53c6-4897-bae0-d986d58f0cc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: TABLET
Route: ORAL
Labeler: Amici Pharma Inc.
Application: ANDA075912
Marketing category: ANDA
Marketing start: 2025-06-21
Substance: KETOCONAZOLE
Active strength: 200 mg/1
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075912-001	KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET / ORAL	AB		2002-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075912-001	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 · 41 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	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL		2002-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL		2002-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL		2002-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL		2002-01-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075912-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2002-01-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075912-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075912-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075912-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075912-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075912-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075912-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075912-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075912-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075912-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075912-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075912-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075912-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075912-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075912-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075912-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075912-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075912-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A075912-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075912-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075912-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075912-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075912-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075912-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075912-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075912-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075912-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075912-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075912-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075912-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075912-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075912-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075912-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075912-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075912-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075912-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075912-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075912-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOCONAZOLE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R9400W927I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197853	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
369f31da-d3c3-49b8-956f-f70598760164	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5	Product name	2	20250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2	Product name	2	20211209
8bc3781f-20ed-678b-44a7-a981e693c65f	Product name	2	20211209
ff3a8c91-648c-300b-467e-10703f514265	Product name	2	20180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69292-224-01	Ketoconazole	100 in 1 BOTTLE	TABLET	100		1

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	Amici Pharma Inc.	369f31da-d3c3-49b8-956f-f70598760164	2025-06-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075912 application number: ANDA075912 ndc (product): 69292-224
KETOCONAZOLE	KETOCONAZOLE	Direct Rx	bc189ce2-3f10-260d-e053-2a95a90ae808	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075912 application number: ANDA075912
KETOCONAZOLE	KETOCONAZOLE	Bryant Ranch Prepack	3ea8a22b-cd61-4623-a11f-43e3396b50fa	2024-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075912 application number: ANDA075912
KETOCONAZOLE	KETOCONAZOLE	A-S Medication Solutions	517c29fc-2a2a-4bd5-a8bb-b464a65d2be0	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075912 application number: ANDA075912
KETOCONAZOLE	KETOCONAZOLE	Burel Pharmaceuticals, LLC	57e81e13-b395-4dbd-b660-3038de41a838	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075912 application number: ANDA075912

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R9400W927I	KETOCONAZOLE	65277-42-1	KETOCONAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197853	ketoconazole 200 MG Oral Tablet	PSN	369f31da-d3c3-49b8-956f-f70598760164	1
197853	ketoconazole 200 MG Oral Tablet	SCD	369f31da-d3c3-49b8-956f-f70598760164	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69292-224-01	69292022401	100 TABLET in 1 BOTTLE (69292-224-01)	100 tablet	2025-06-21	No	No	Current