Ketoconazole

Product NDC: 82804-091
11-digit product format: 828040091
Labeler code: 82804
Product ID: 82804-091_36e0bdcb-845c-452f-ad5a-a116ad657a3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole Cream, 2%
Dosage form: CREAM
Route: TOPICAL
Labeler: Proficient Rx LP
Application: ANDA212443
Marketing category: ANDA
Marketing start: 2021-05-27
Substance: KETOCONAZOLE
Active strength: 20 mg/g
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
A212443-001	KETOCONAZOLE	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2021-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212443-001	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.

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	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2021-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2021-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2021-05-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212443-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212443-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212443-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212443-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212443-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212443-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212443-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212443-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212443-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212443-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212443-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212443-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212443-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212443-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212443-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212443-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212443-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212443-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212443-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212443-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212443-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212443-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212443-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212443-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212443-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212443-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212443-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212443-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212443-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212443-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212443-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212443-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212443-001	AB	1	`a50c72e98297…`

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/g

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
203088	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
36e0bdcb-845c-452f-ad5a-a116ad657a3a	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
82804-091-15	Ketoconazole	15 g in 1 TUBE	CREAM	15		1
82804-091-15	Ketoconazole	1 in 1 CARTON	CREAM	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-091-15	GM - Gram	82804-091	a3d15dcc-354e-45b2-87fe-2211624322eb	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-091	KETOCONAZOLE (KETOCONAZOLE CREAM, 2%) CREAM [PROFICIENT RX LP]	1	Current NDC, 2 package rows	20240407_36e0bdcb-845c-452f-ad5a-a116ad657a3a.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE CREAM, 2%	Preferred Pharmaceuticals Inc.	abc2446c-cdc2-48fe-80f2-cf0038d2a85e	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole Cream	KETOCONAZOLE CREAM	Direct_Rx	f422aaa8-3cce-5989-e053-2a95a90a5205	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	ASCLEMED USA INC.	6f1a5365-99df-4169-9382-14c2643e561d	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	Sportpharm LLC	d68f090d-82ea-413f-ab76-9254a8888736	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	REMEDYREPACK INC.	ea56cddf-94c9-46b6-8791-995b741cfbd7	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	Encube Ethicals, Inc.	59188ef7-5bc9-4acc-bbff-8712c41e5f77	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	A-S Medication Solutions	750bcfc3-b0e4-407e-ad12-e81b183f3b00	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	NuCare Pharmaceuticals,Inc.	05f9938a-1577-adec-e063-6294a90af349	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	Proficient Rx LP	36e0bdcb-845c-452f-ad5a-a116ad657a3a	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443 ndc (product): 82804-091

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
203088	ketoconazole 2 % Topical Cream	PSN	36e0bdcb-845c-452f-ad5a-a116ad657a3a	1
203088	ketoconazole 20 MG/ML Topical Cream	SCD	36e0bdcb-845c-452f-ad5a-a116ad657a3a	1
203088	ketoconazole 2 % Topical Cream	SY	36e0bdcb-845c-452f-ad5a-a116ad657a3a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-091-15	82804009115	1 TUBE in 1 CARTON (82804-091-15) / 15 g in 1 TUBE	1 tube	2024-03-28	No	No	Current