Ketoconazole

Product NDC: 71713-097
11-digit product format: 717130097
Labeler code: 71713
Product ID: 71713-097_462a71f3-fd40-997f-e063-6294a90abb4d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: SHAMPOO, SUSPENSION
Route: TOPICAL
Labeler: THIRTY MADISON INC
Application: ANDA076942
Marketing category: ANDA
Marketing start: 2005-04-11
Substance: KETOCONAZOLE
Active strength: 20 mg/mL
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: 2026-12-31
Current FDA listing: Yes

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
A076942-001	KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2005-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076942-001	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	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`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	A076942-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076942-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076942-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076942-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076942-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076942-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076942-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076942-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076942-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076942-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076942-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076942-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076942-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076942-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076942-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076942-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076942-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076942-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076942-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076942-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076942-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076942-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076942-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076942-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076942-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076942-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076942-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076942-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076942-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076942-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076942-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076942-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076942-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076942-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076942-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076942-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076942-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076942-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076942-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076942-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ketoconazole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOCONAZOLE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R9400W927I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106336	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1f5cd9f4-0db4-4062-b5ec-c33611265e02	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5	Product name	2	20250331
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2	Product name	2	20211209
8bc3781f-20ed-678b-44a7-a981e693c65f	Product name	2	20211209
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
ff3a8c91-648c-300b-467e-10703f514265	Product name	2	20180809
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71713-097-04	Ketoconazole	120 mL in 1 BOTTLE, PLASTIC	SHAMPOO, SUSPENSION	120		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71713-097-04	ML - Milliliter	71713-097	4c6c41e0-e1f8-43ba-b31a-dff9ba740db7	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71713-097	KETOCONAZOLE SHAMPOO, SUSPENSION [THIRTY MADISON INC]	4	Current NDC, Legacy NDC, 1 package rows	20230219_1f5cd9f4-0db4-4062-b5ec-c33611265e02.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	Preferred Pharmaceuticals Inc.	d59df5bf-bfa6-45fa-81f6-8c8ee2f24cf8	2026-05-14	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942
Ketoconazole	KETOCONAZOLE	THIRTY MADISON INC	1f5cd9f4-0db4-4062-b5ec-c33611265e02	2025-12-17	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942 ndc (product): 71713-097
Ketoconazole	KETOCONAZOLE	Preferred Pharmaceuticals Inc.	39d31bed-9caa-41bb-afdb-25fc18609c14	2025-04-24	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	a884bad7-df8c-45de-8c4f-42034b40e425	2025-04-23	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942
Ketoconazole	KETOCONAZOLE	Cosette Pharmaceuticals, Inc.	2d7c8dd1-59b5-2645-e063-6394a90a5bda	2025-02-06	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	c29d4ddc-aa1c-41c6-99ce-9aff35d213f6	2023-09-25	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942
Ketoconazole	KETOCONAZOLE	Proficient Rx LP	cb1908da-443d-40b8-b8c7-b115bc2d37e0	2022-11-01	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942
Ketoconazole	KETOCONAZOLE	TOLMAR Inc.	7036d1f2-c3f9-41d4-bc72-dd70e1691128	2020-06-03	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942

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
106336	ketoconazole 2 % Medicated Shampoo	PSN	1f5cd9f4-0db4-4062-b5ec-c33611265e02	5
106336	ketoconazole 20 MG/ML Medicated Shampoo	SCD	1f5cd9f4-0db4-4062-b5ec-c33611265e02	5
106336	ketoconazole 2 % Medicated Shampoo	SY	1f5cd9f4-0db4-4062-b5ec-c33611265e02	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71713-097-04	71713009704	120 mL in 1 BOTTLE, PLASTIC (71713-097-04)	120 ml	2005-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketoconazole Shampoo, 2% For topical application only. Rx only	THIRTY MADISON INC	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	5