Ketoconazole

Product NDC: 68788-9708
11-digit product format: 687889708
Labeler code: 68788
Product ID: 68788-9708_cf776939-7ebf-4945-b3a2-43e201ad8169
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA075319
Marketing category: ANDA
Marketing start: 2013-02-05
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-9708		D	Discontinued by firm	2026-09-09
excluded package	package	68788-9708	68788-9708-1	D	Discontinued by firm	2026-09-09
excluded package	package	68788-9708	68788-9708-3	D	Discontinued by firm	2026-09-09
excluded package	package	68788-9708	68788-9708-6	D	Discontinued by firm	2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9708-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9708-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9708-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9708-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9708-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9708-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9708-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9708-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9708-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9708-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9708-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9708-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9708-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9708-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9708-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9708-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9708-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9708-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9708-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9708-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9708-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9708-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9708-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9708-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9708-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9708-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9708-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9708-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9708-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9708-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-9708-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-9708-6	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-9708-3	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9708-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9708-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9708-3	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075319-001	KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075319-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A075319-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075319-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075319-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075319-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075319-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075319-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075319-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075319-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075319-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075319-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075319-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075319-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075319-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075319-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075319-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075319-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075319-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075319-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075319-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075319-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075319-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075319-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075319-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075319-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075319-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075319-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075319-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075319-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075319-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075319-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075319-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075319-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075319-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075319-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075319-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075319-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075319-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075319-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075319-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075319-001	AB	1	`e64feba35796…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
povidones	INACTIVE INGREDIENT	FZ989GH94E	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	4baebcab-a237-42c0-9183-6f447a44e371	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075319 application number: ANDA075319
Ketoconazole	KETOCONAZOLE	Golden State Medical Supply, Inc.	a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075319 application number: ANDA075319
Ketoconazole	KETOCONAZOLE	Sun Pharmaceutical Industries, Inc.	8ca815a8-bccb-4ee2-a042-922373329cae	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075319 application number: ANDA075319
Ketoconazole	KETOCONAZOLE	Direct_Rx	f5dc1e67-639f-5476-e053-2995a90a4210	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075319 application number: ANDA075319

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-9708-1	68788970801	10 TABLET in 1 BOTTLE (68788-9708-1)	10 tablet	2013-02-05	0000-00-00	No	No	Current
68788-9708-3	68788970803	30 TABLET in 1 BOTTLE (68788-9708-3)	30 tablet	2013-02-05	0000-00-00	No	No	Current
68788-9708-6	68788970806	60 TABLET in 1 BOTTLE (68788-9708-6)	60 tablet	2013-02-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketoconazole Tablets USP, 200 MG	Preferred Pharmaceuticals, Inc.	2020-06-19	HUMAN PRESCRIPTION DRUG LABEL	7