Ketoconazole

Product NDC: 71085-008
Requested package NDC: 71085-008-60
11-digit product format: 710850008
Labeler code: 71085
Product ID: 71085-008_5bc5a7b0-f5db-91b4-e063-6294a90aeeb1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: CREAM
Route: TOPICAL
Labeler: IPG PHARMACEUTICALS, INC.
Application: ANDA075638
Marketing category: ANDA
Marketing start: 2026-09-10
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: 2027-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71085-008	71085-008-60	I	Inactivated by FDA		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71085-008	71085-008-60	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075638-001	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Ketoconazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOCONAZOLE	20 mg/g

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-12-29	Ketoconazole Cream, 2%
2025-12-29	Ketoconazole Cream, 2%
2025-07-29	Ketoconazole Cream, 2%
2025-07-29	Ketoconazole Cream, 2%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71085-008-60	GM - Gram	71085-008	68b3fd33-5acb-4e1e-a6a5-7bd734d22270	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71085-008	KETOCONAZOLE CREAM [IPG PHARMACEUTICALS, INC.]	1	Current NDC, Legacy NDC	20170218_51363e79-8681-4b68-aebf-09323c95809b.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 · 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
71085-008-60	71085000860	1 TUBE in 1 CARTON (71085-008-60) > 60 g in 1 TUBE	1 tube	2016-12-21	0000-00-00	No	No	Current