KETOCONAZOLE

Product NDC: 66267-400
11-digit product format: 662670400
Labeler code: 66267
Product ID: 66267-400_da727156-1daf-5694-e053-2a95a90acbd0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: KETOCONAZOLE
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA210457
Marketing category: ANDA
Marketing start: 2018-06-26
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66267-400		I	Inactivated by FDA		2026-08-17
excluded package	package	66267-400	66267-400-20	I	Inactivated by FDA		2026-08-17

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 · 18 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66267-400-20	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66267-400-20	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66267-400-20	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66267-400-20	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66267-400-20	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66267-400-20	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66267-400-20	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66267-400-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66267-400-20	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A210457-001	KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET / ORAL	AB		2018-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210457-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210457-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	2018-06-18	`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	A210457-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210457-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210457-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210457-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210457-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210457-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210457-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210457-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210457-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210457-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210457-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210457-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210457-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210457-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210457-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210457-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210457-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210457-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210457-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210457-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210457-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210457-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210457-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210457-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210457-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210457-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210457-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210457-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210457-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210457-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210457-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210457-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210457-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210457-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210457-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210457-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210457-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210457-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210457-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210457-001	AB	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66267-400-20	2025-01-30	C162847	48780-1	2cef2736-7080-d83d-e063-dadaa90ab31f	Ketoconazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66267-400-20	KETOCONAZOLE	20 in 1 BOTTLE	TABLET	20		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66267-400	KETOCONAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]	3	Legacy NDC, 1 package rows	20220318_aae6c08a-8610-b833-e053-2a95a90a3e6b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KETOCONAZOLE	KETOCONAZOLE	PD-Rx Pharmaceuticals, Inc.	f162e616-21b4-49b1-b437-15e21001a6f0	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210457 application number: ANDA210457
KETOCONAZOLE	KETOCONAZOLE	Strides Pharma Science Limited	6d4be760-c723-4f54-a854-12c61cf91703	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210457 application number: ANDA210457

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	aae6c08a-8610-b833-e053-2a95a90a3e6b	3
197853	ketoconazole 200 MG Oral Tablet	SCD	aae6c08a-8610-b833-e053-2a95a90a3e6b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66267-400-20	66267040020	20 TABLET in 1 BOTTLE (66267-400-20)	20 tablet	2020-07-20	0000-00-00	No	No	Current