Ketoconazole

Product NDC: 63629-8675
11-digit product format: 636298675
Labeler code: 63629
Product ID: 63629-8675_01cb5b3b-9fb1-44a8-92a1-1954ba3968a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: SHAMPOO, SUSPENSION
Route: TOPICAL
Labeler: Bryant Ranch Prepack
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 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
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 · 41 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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076419-001	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
b200ef76-5ea1-4253-bea5-1e8db0294510	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8675-1	Ketoconazole	120 mL in 1 BOTTLE	SHAMPOO, SUSPENSION	120		107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8675-1	ML - Milliliter	63629-8675	975c7a79-3159-415f-8d66-5ffd8bac1ff9	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8675	KETOCONAZOLE SHAMPOO, SUSPENSION [BRYANT RANCH PREPACK]	107	Current NDC, Legacy NDC, 1 package rows	20240808_b200ef76-5ea1-4253-bea5-1e8db0294510.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 ndc (product): 63629-8675

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8675-1	63629867501	120 mL in 1 BOTTLE (63629-8675-1)	120 ml	2022-02-09	0000-00-00	No	No	Current