KETOCONAZOLE

Product NDC: 71337-035
11-digit product format: 713370035
Labeler code: 71337
Product ID: 71337-035_efe0105c-ddef-4d3b-9be9-f9ed478b0f03
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketoconazole
Dosage form: TABLET
Route: ORAL
Labeler: Havix Group Inc d-b-a Aavis Pharmaceuticals
Application: ANDA075912
Marketing category: ANDA
Marketing start: 2020-11-12
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71337-035		D	Discontinued by firm	2026-08-10
excluded package	package	71337-035	71337-035-01	D	Discontinued by firm	2026-08-10
excluded package	package	71337-035	71337-035-03	D	Discontinued by firm	2026-08-10

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71337-035-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71337-035-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71337-035-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71337-035-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71337-035-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71337-035-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71337-035-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71337-035-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71337-035-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71337-035-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71337-035-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71337-035-03	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71337-035-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71337-035-03	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71337-035-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71337-035-03	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71337-035-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71337-035-03	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71337-035-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71337-035-03	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71337-035-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71337-035-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71337-035-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71337-035-03	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	71337-035-03	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	71337-035-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	71337-035-03	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	71337-035-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	71337-035-03	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	71337-035-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71337-035-01	2023-08-11	Ketoconazole Tablets, USP 200 mg Rx Only
71337-035-03	2023-08-11	Ketoconazole Tablets, USP 200 mg Rx Only
71337-035-01	2022-01-28	Ketoconazole Tablets, USP 200 mg Rx Only
71337-035-03	2022-01-28	Ketoconazole Tablets, USP 200 mg Rx Only

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71337-035-01	71337003501	100 TABLET in 1 BOTTLE (71337-035-01)	100 tablet	2020-11-13	0000-00-00	No	No	Current
71337-035-03	71337003503	30 TABLET in 1 BOTTLE (71337-035-03)	30 tablet	2020-11-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketoconazole Tablets, USP 200 mg Rx Only	Havix Group Inc d-b-a Aavis Pharmaceuticals	2020-11-11	HUMAN PRESCRIPTION DRUG LABEL	2