ketoconazole

Product NDC: 63629-8677
11-digit product format: 636298677
Labeler code: 63629
Product ID: 63629-8677_6e2c78c5-12df-445d-a2ec-d25482b4ecd8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketoconazole
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA091550
Marketing category: ANDA
Marketing start: 2011-08-30
Substance: KETOCONAZOLE
Active strength: 2 g/100g
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
A091550-001	KETOCONAZOLE	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB		2011-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091550-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`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	A091550-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091550-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091550-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091550-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091550-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091550-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091550-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091550-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091550-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091550-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091550-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091550-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091550-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091550-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091550-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091550-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091550-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091550-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091550-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091550-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091550-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091550-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091550-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091550-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091550-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091550-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091550-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091550-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091550-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091550-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091550-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091550-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091550-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091550-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091550-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091550-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091550-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091550-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091550-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091550-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOCONAZOLE	2 g/100g

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
728550	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
77989858-9f7a-45d6-97fb-deba1cba8fe8	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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
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
63629-8677-1	ketoconazole	100 g in 1 CANISTER	AEROSOL, FOAM	100		105
63629-8677-1	ketoconazole	1 in 1 CARTON	AEROSOL, FOAM	1		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8677-1	GM - Gram	63629-8677	00f192a2-be15-4166-9821-c4768079e203	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8677	KETOCONAZOLE AEROSOL, FOAM [BRYANT RANCH PREPACK]	105	Current NDC, Legacy NDC, 2 package rows	20241024_77989858-9f7a-45d6-97fb-deba1cba8fe8.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	Bryant Ranch Prepack	a878a39d-6d26-4ede-9667-b3e201ffc337	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	65dd4435-99f2-4383-b307-ba5bce9f1ca9	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	ac98307e-315a-4fbd-81cb-cd936f2bfbae	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550
Ketodan	KETOCONAZOLE	Medimetriks Pharmaceuticals, Inc.	62f19bd8-926e-4e6b-9097-d81b894b95cc	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	77989858-9f7a-45d6-97fb-deba1cba8fe8	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550 ndc (product): 63629-8677
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	513370d5-2e9f-4677-a0f2-63ff76142909	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550
ketoconazole	KETOCONAZOLE	Padagis Israel Pharmaceuticals Ltd	9b65f632-a98d-400e-9ec3-84dea581d6a3	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550

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
728550	ketoconazole 2 % Topical Foam	PSN	77989858-9f7a-45d6-97fb-deba1cba8fe8	105
728550	ketoconazole 20 MG/ML Topical Foam	SCD	77989858-9f7a-45d6-97fb-deba1cba8fe8	105
728550	ketoconazole 2 % Topical Foam	SY	77989858-9f7a-45d6-97fb-deba1cba8fe8	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8677-1	63629867701	1 CANISTER in 1 CARTON (63629-8677-1) / 100 g in 1 CANISTER	1 canister	2011-08-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ketoconazole - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-10-08	HUMAN PRESCRIPTION DRUG LABEL	105