Ketoconazole

Product NDC: 68071-3512
11-digit product format: 680713512
Labeler code: 68071
Product ID: 68071-3512_2d04d27d-6b6d-e729-e063-6394a90ab60b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole Cream, 2%
Dosage form: CREAM
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
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

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3512-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3512-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3512-5	`0efc9e666f02…`	`f202fb6c5f17…`

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
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
2026-08-18 06:07:40	2026-07	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2021-05-20	`caaa826d4ba7…`
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
2026-08-18 06:07:40	2026-07	A212443-001	AB	1	`caaa826d4ba7…`
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
05f9938a-1577-adec-e063-6294a90af349	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
68071-3512-5	2025-02-01	C162847	48780-1	2cef2736-7527-d83d-e063-dadaa90ab31f	KETOCONAZOLE CREAM Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3512-5	Ketoconazole	15 g in 1 TUBE	CREAM	15		2
68071-3512-5	Ketoconazole	15 in 1 CARTON	CREAM	15		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3512	KETOCONAZOLE (KETOCONAZOLE CREAM, 2%) CREAM [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 2 package rows	20250202_05f9938a-1577-adec-e063-6294a90af349.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 ndc (product): 68071-3512
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

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	05f9938a-1577-adec-e063-6294a90af349	2
203088	ketoconazole 20 MG/ML Topical Cream	SCD	05f9938a-1577-adec-e063-6294a90af349	2
203088	ketoconazole 2 % Topical Cream	SY	05f9938a-1577-adec-e063-6294a90af349	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3512-5	68071351205	15 TUBE in 1 CARTON (68071-3512-5) / 15 g in 1 TUBE	15 tube	2023-09-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KETOCONAZOLE CREAM Rx only	NuCare Pharmaceuticals,Inc.	2025-01-31	HUMAN PRESCRIPTION DRUG LABEL	2