Ketoconazole

Product NDC: 45802-465
11-digit product format: 458020465
Labeler code: 45802
Product ID: 45802-465_85a7e4b1-78a5-41e9-996c-026c58e487c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: SHAMPOO, SUSPENSION
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA076419
Marketing category: ANDA
Marketing start: 2010-01-19
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 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…`

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/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
99da5233-2760-46f6-8fb3-d9df5da70bfb	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
45802-465-64	Ketoconazole	120 mL in 1 BOTTLE	SHAMPOO, SUSPENSION	120		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-465-64	ML - Milliliter	45802-465	75e5c0fb-5936-4154-bb25-d2ee20a5376e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOCONAZOLE	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
KETOCONAZOLE	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
DISODIUM LAURETH SULFOSUCCINATE	INACTIVE INGREDIENT	D6DH1DTN7E	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
PEG-120 METHYL GLUCOSE DIOLEATE	INACTIVE INGREDIENT	YM0K64F20V	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
SODIUM LAURETH-3 SULFATE	INACTIVE INGREDIENT	BPV390UAP0	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE SHAMPOO, SUSPENSION [PERRIGO NEW YORK INC]	6
KETOCONAZOLE	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
KETOCONAZOLE	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
DISODIUM LAURETH SULFOSUCCINATE	INACTIVE INGREDIENT	D6DH1DTN7E	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
PEG-120 METHYL GLUCOSE DIOLEATE	INACTIVE INGREDIENT	YM0K64F20V	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
SODIUM LAURETH-3 SULFATE	INACTIVE INGREDIENT	BPV390UAP0	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
KETOCONAZOLE	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	1
KETOCONAZOLE	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
KETOCONAZOLE	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
KETOCONAZOLE	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	KETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
DISODIUM LAURETH SULFOSUCCINATE	INACTIVE INGREDIENT	D6DH1DTN7E	KETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
DISODIUM LAURETH SULFOSUCCINATE	INACTIVE INGREDIENT	D6DH1DTN7E	KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	KETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	1
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	KETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
PEG-120 METHYL GLUCOSE DIOLEATE	INACTIVE INGREDIENT	YM0K64F20V	KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	1
PEG-120 METHYL GLUCOSE DIOLEATE	INACTIVE INGREDIENT	YM0K64F20V	KETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE SHAMPOO, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-465	KETOCONAZOLE SHAMPOO, SUSPENSION [PADAGIS ISRAEL PHARMACEUTICALS LTD]	14	Current NDC, Legacy NDC, 1 package rows	20250129_99da5233-2760-46f6-8fb3-d9df5da70bfb.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 ndc (product): 45802-465
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	b200ef76-5ea1-4253-bea5-1e8db0294510	107
106336	ketoconazole 20 MG/ML Medicated Shampoo	SCD	b200ef76-5ea1-4253-bea5-1e8db0294510	107
106336	ketoconazole 2 % Medicated Shampoo	SY	b200ef76-5ea1-4253-bea5-1e8db0294510	107
106336	ketoconazole 2 % Medicated Shampoo	PSN	6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf	100
106336	ketoconazole 20 MG/ML Medicated Shampoo	SCD	6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf	100
106336	ketoconazole 2 % Medicated Shampoo	SY	6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf	100
106336	ketoconazole 2 % Medicated Shampoo	PSN	99da5233-2760-46f6-8fb3-d9df5da70bfb	14
106336	ketoconazole 20 MG/ML Medicated Shampoo	SCD	99da5233-2760-46f6-8fb3-d9df5da70bfb	14
106336	ketoconazole 2 % Medicated Shampoo	SY	99da5233-2760-46f6-8fb3-d9df5da70bfb	14
106336	ketoconazole 2 % Medicated Shampoo	PSN	098afc02-ac71-4214-9fe1-8b519b173bdf	11
106336	ketoconazole 20 MG/ML Medicated Shampoo	SCD	098afc02-ac71-4214-9fe1-8b519b173bdf	11
106336	ketoconazole 2 % Medicated Shampoo	SY	098afc02-ac71-4214-9fe1-8b519b173bdf	11
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
106336	ketoconazole 2 % Medicated Shampoo	PSN	4578c84a-d438-6740-e063-6294a90a0151	1
106336	ketoconazole 2 % Medicated Shampoo	PSN	b59504cb-dfdd-4c5c-9686-1af6d97306c8	1
106336	ketoconazole 2 % Medicated Shampoo	PSN	d0fcab34-5451-456a-a75a-b1365d5dbc2c	1
106336	ketoconazole 2 % Medicated Shampoo	PSN	dfac6776-1151-4d01-a099-9de11c9dc7fa	1
106336	ketoconazole 20 MG/ML Medicated Shampoo	SCD	4578c84a-d438-6740-e063-6294a90a0151	1
106336	ketoconazole 20 MG/ML Medicated Shampoo	SCD	b59504cb-dfdd-4c5c-9686-1af6d97306c8	1
106336	ketoconazole 20 MG/ML Medicated Shampoo	SCD	d0fcab34-5451-456a-a75a-b1365d5dbc2c	1
106336	ketoconazole 20 MG/ML Medicated Shampoo	SCD	dfac6776-1151-4d01-a099-9de11c9dc7fa	1
106336	ketoconazole 2 % Medicated Shampoo	SY	4578c84a-d438-6740-e063-6294a90a0151	1
106336	ketoconazole 2 % Medicated Shampoo	SY	b59504cb-dfdd-4c5c-9686-1af6d97306c8	1
106336	ketoconazole 2 % Medicated Shampoo	SY	d0fcab34-5451-456a-a75a-b1365d5dbc2c	1
106336	ketoconazole 2 % Medicated Shampoo	SY	dfac6776-1151-4d01-a099-9de11c9dc7fa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-465-64	45802046564	120 mL in 1 BOTTLE (45802-465-64)	120 ml	2010-01-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketoconazole Shampoo, 2%	NuCare Pharmaceuticals,Inc.	2025-12-08	HUMAN PRESCRIPTION DRUG LABEL	1
Ketoconazole Shampoo, 2%	Bryant Ranch Prepack	2025-10-24	HUMAN PRESCRIPTION DRUG LABEL	100
Ketoconazole Shampoo, 2%	RPK Pharmaceuticals, Inc.	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	2
Ketoconazole Shampoo, 2%	Bryant Ranch Prepack	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	1
Ketoconazole Shampoo, 2%	Padagis Israel Pharmaceuticals Ltd	2024-05-31	HUMAN PRESCRIPTION DRUG LABEL	15
Ketoconazole Shampoo, 2%	Bryant Ranch Prepack	2024-03-15	HUMAN PRESCRIPTION DRUG LABEL	107
Ketoconazole Shampoo, 2%	Preferred Pharmaceuticals, Inc.	2022-07-11	HUMAN PRESCRIPTION DRUG LABEL	11
Ketoconazole Shampoo, 2%	A-S Medication Solutions	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	10
Ketoconazole Shampoo, 2%	Aidarex Pharmaceuticals LLC	2013-10-02	HUMAN PRESCRIPTION DRUG LABEL	1
Ketoconazole - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-03-10	HUMAN PRESCRIPTION DRUG LABEL	1