Ketoconazole

Product NDC: 68788-9915
Requested package NDC: 68788-9915-3
11-digit product format: 687889915
Labeler code: 68788
Product ID: 68788-9915_390b9a29-fdd7-40b2-80b1-f766c1f4e44a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: CREAM
Route: TOPICAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA075638
Marketing category: ANDA
Marketing start: 2012-01-30
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	68788-9915	68788-9915-3	D	Discontinued by firm		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 · 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 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
A075638-001	KETOZOLE	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2002-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075638-001	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	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`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	A075638-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075638-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075638-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075638-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075638-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075638-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075638-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075638-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075638-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075638-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075638-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075638-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075638-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075638-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075638-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075638-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075638-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075638-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075638-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075638-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075638-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075638-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075638-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075638-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075638-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075638-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075638-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075638-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075638-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075638-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075638-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075638-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075638-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075638-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075638-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075638-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075638-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075638-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075638-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075638-001	AB	1	`e64feba35796…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE CREAM [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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	NORTHSTAR RX LLC	bf3e48fd-e063-42e6-acd1-580ddc6e93be	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638
Ketoconazole	KETOCONAZOLE	Golden State Medical Supply, Inc.	3e3cde4b-939f-4837-9920-bb6bb8416bd6	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638
Ketoconazole	KETOCONAZOLE	Sun Pharmaceutical Industries, Inc.	39b85d6a-9133-42e6-b7f8-58f045e9b9f0	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals,Inc.	570acb82-0c6f-0b98-e054-00144ff8d46c	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	8ef1117d-0b63-4c26-beaa-7667b2387e14	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638
Ketoconazole	KETOCONAZOLE	Proficient Rx LP	4f08caf2-a57c-4146-9289-532711bbdbcd	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638

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
68788-9915-3	68788991503	1 TUBE in 1 CARTON (68788-9915-3) > 30 g in 1 TUBE	1 tube	2012-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketoconazole Cream, 2%	Preferred Pharmaceuticals, Inc.	2022-07-08	HUMAN PRESCRIPTION DRUG LABEL	7