Ketoconazole

Product NDC: 70518-3367
Requested package NDC: 70518-3367-0
11-digit product format: 705183367
Labeler code: 70518
Product ID: 70518-3367_e38cfa58-a49f-26fd-e053-2995a90a3a08
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: CREAM
Route: TOPICAL
Labeler: REMEDYREPACK INC.
Application: ANDA075581
Marketing category: ANDA
Marketing start: 2022-02-16
Marketing end: 0000-00-00
Substance: KETOCONAZOLE
Active strength: 20 mg/g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3367	70518-3367-0	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

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

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
A075581-001	KETOCONAZOLE	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2000-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075581-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2000-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2000-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A075581-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075581-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075581-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075581-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075581-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075581-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075581-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075581-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075581-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075581-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075581-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075581-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075581-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075581-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075581-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075581-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075581-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075581-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075581-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075581-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075581-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075581-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075581-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075581-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075581-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075581-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075581-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075581-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075581-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075581-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075581-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075581-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075581-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075581-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075581-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075581-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075581-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075581-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075581-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075581-001	AB	1	`cb3db0bc1861…`

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	02a348b0-1325-4298-8813-83970da32c7a	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075581 application number: ANDA075581
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	dc635682-170d-46ad-a9ba-6a75c6e0950e	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075581 application number: ANDA075581
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	b3b99c8b-4512-4972-935d-602d4b8325c4	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075581 application number: ANDA075581
Ketoconazole	KETOCONAZOLE	Teva Pharmaceuticals USA, Inc.	7fc47a6a-3714-4598-ae3b-d5a229262c21	2021-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075581 application number: ANDA075581

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
70518-3367-0	70518336700	1 TUBE in 1 CARTON (70518-3367-0) > 30 g in 1 TUBE	1 tube	2022-02-16	0000-00-00	No	No	Current