Ketoconazole

Product NDC: 50090-1220
Requested package NDC: 50090-1220-0
11-digit product format: 500901220
Labeler code: 50090
Product ID: 50090-1220_872126b2-e2bb-4a0f-aa98-d7c143fb5d0b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: SHAMPOO, SUSPENSION
Route: TOPICAL
Labeler: A-S Medication Solutions
Application: ANDA076419
Marketing category: ANDA
Marketing start: 2010-01-19
Marketing end: 0000-00-00
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: 2022-12-31
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	50090-1220	50090-1220-0	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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A076419-001	KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076419-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2004-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2004-01-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2004-01-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2004-01-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2004-01-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`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	A076419-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076419-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076419-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076419-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076419-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076419-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076419-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076419-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076419-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076419-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076419-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076419-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076419-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076419-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076419-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076419-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076419-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076419-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076419-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076419-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076419-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076419-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076419-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076419-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076419-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076419-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076419-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076419-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076419-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076419-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076419-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076419-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076419-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076419-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076419-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076419-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076419-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076419-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076419-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076419-001	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
50090-1220-0	2023-01-30	C162847	48780-1	f386c649-ab4b-0266-e053-dadaa90a7c1a	Ketoconazole Shampoo, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1220-0	Ketoconazole	120 mL in 1 BOTTLE	SHAMPOO, SUSPENSION	120		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1220-0	ML - Milliliter	50090-1220	5bbecd7c-10c2-4835-9054-ebed1b7441d4	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1220	KETOCONAZOLE SHAMPOO, SUSPENSION [A-S MEDICATION SOLUTIONS]	10	Legacy NDC, 1 package rows	20210223_2c5e02ba-c165-4ffb-bd05-fbd4243725b7.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals, Inc.	53492ad1-baca-a7f6-e063-6294a90a2990	2026-06-02	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals,Inc.	4578c84a-d438-6740-e063-6294a90a0151	2025-12-08	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419
Ketoconazole	KETOCONAZOLE	Northstar Rx LLC	c4f711dc-d0ea-4beb-9a78-b7e3594ee4be	2025-12-01	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf	2025-10-24	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	d0fcab34-5451-456a-a75a-b1365d5dbc2c	2024-06-20	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419
Ketoconazole	KETOCONAZOLE	Padagis Israel Pharmaceuticals Ltd	99da5233-2760-46f6-8fb3-d9df5da70bfb	2024-05-31	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	b200ef76-5ea1-4253-bea5-1e8db0294510	2024-03-15	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419

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	2c5e02ba-c165-4ffb-bd05-fbd4243725b7	10
106336	ketoconazole 20 MG/ML Medicated Shampoo	SCD	2c5e02ba-c165-4ffb-bd05-fbd4243725b7	10
106336	ketoconazole 2 % Medicated Shampoo	SY	2c5e02ba-c165-4ffb-bd05-fbd4243725b7	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1220-0	50090122000	120 mL in 1 BOTTLE (50090-1220-0)	120 ml	2014-11-28	0000-00-00	No	No	Current