Ketoconazole

Product NDC: 51672-1298
11-digit product format: 516721298
Labeler code: 51672
Product ID: 51672-1298_395c0795-2343-b8c0-e063-6294a90a5505
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: CREAM
Route: TOPICAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA075638
Marketing category: ANDA
Marketing start: 2002-12-18
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 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
A075638-001	KETOZOLE	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2002-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075638-001	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	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`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	A075638-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075638-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075638-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075638-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075638-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075638-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075638-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075638-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075638-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075638-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075638-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075638-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075638-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075638-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075638-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075638-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075638-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075638-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075638-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075638-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075638-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075638-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075638-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075638-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075638-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075638-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075638-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075638-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075638-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075638-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075638-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075638-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075638-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075638-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075638-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075638-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075638-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075638-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075638-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075638-001	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	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
39b85d6a-9133-42e6-b7f8-58f045e9b9f0	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
51672-1298-1	Ketoconazole	1 in 1 CARTON	CREAM	1		4
51672-1298-1	Ketoconazole	15 g in 1 TUBE	CREAM	15		4
51672-1298-2	Ketoconazole	1 in 1 CARTON	CREAM	1		4
51672-1298-2	Ketoconazole	30 g in 1 TUBE	CREAM	30		4
51672-1298-3	Ketoconazole	1 in 1 CARTON	CREAM	1		4
51672-1298-3	Ketoconazole	60 g in 1 TUBE	CREAM	60		4
51672-1298-2	Podiatrole	1 in 1 CARTON	CREAM		20 mg in 1g	1
51672-1298-2	Podiatrole	30 g in 1 TUBE	CREAM	60 g	20 mg in 1g	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-1298-1	GM - Gram	51672-1298	d18efac5-493b-432d-a889-141da374f86f	1	2012-07-24
51672-1298-2	GM - Gram	51672-1298	ed634d09-35c4-49de-8c4a-140edac5f2aa	1	2012-07-24
51672-1298-3	GM - Gram	51672-1298	820a4a2a-778a-44fc-9192-b68f58617cf7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
Butylated Hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-1298	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3	Current NDC, Legacy NDC, 6 package rows	20240210_39b85d6a-9133-42e6-b7f8-58f045e9b9f0.zip
51672-1298	PODIATROLE (KETOCONAZOLE 2% AND UREA 20%) KIT [V2 PHARMA, LLC]	1	Current NDC, Legacy NDC	20230219_ebd520d0-8069-490f-a0d7-356d1e7c3dfd.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	NORTHSTAR RX LLC	bf3e48fd-e063-42e6-acd1-580ddc6e93be	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638
Ketoconazole	KETOCONAZOLE	Golden State Medical Supply, Inc.	3e3cde4b-939f-4837-9920-bb6bb8416bd6	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638
Ketoconazole	KETOCONAZOLE	Sun Pharmaceutical Industries, Inc.	39b85d6a-9133-42e6-b7f8-58f045e9b9f0	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638 ndc (product): 51672-1298
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals,Inc.	570acb82-0c6f-0b98-e054-00144ff8d46c	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	8ef1117d-0b63-4c26-beaa-7667b2387e14	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638
Ketoconazole	KETOCONAZOLE	Proficient Rx LP	4f08caf2-a57c-4146-9289-532711bbdbcd	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638

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	2b3bdb6e-2b48-4979-ae08-bd17cd74130e	11
203088	ketoconazole 20 MG/ML Topical Cream	SCD	2b3bdb6e-2b48-4979-ae08-bd17cd74130e	11
203088	ketoconazole 2 % Topical Cream	SY	2b3bdb6e-2b48-4979-ae08-bd17cd74130e	11
203088	ketoconazole 2 % Topical Cream	PSN	4848af6a-26fb-49cd-a2f0-2b5d7f34e586	7
203088	ketoconazole 20 MG/ML Topical Cream	SCD	4848af6a-26fb-49cd-a2f0-2b5d7f34e586	7
203088	ketoconazole 2 % Topical Cream	SY	4848af6a-26fb-49cd-a2f0-2b5d7f34e586	7
203088	ketoconazole 2 % Topical Cream	PSN	570acb82-0c6f-0b98-e054-00144ff8d46c	6
203088	ketoconazole 20 MG/ML Topical Cream	SCD	570acb82-0c6f-0b98-e054-00144ff8d46c	6
203088	ketoconazole 2 % Topical Cream	SY	570acb82-0c6f-0b98-e054-00144ff8d46c	6
203088	ketoconazole 2 % Topical Cream	PSN	c2a85a63-793f-4354-80a7-c475ae7bdfb5	5
203088	ketoconazole 2 % Topical Cream	PSN	4f08caf2-a57c-4146-9289-532711bbdbcd	5
203088	ketoconazole 20 MG/ML Topical Cream	SCD	4f08caf2-a57c-4146-9289-532711bbdbcd	5
203088	ketoconazole 20 MG/ML Topical Cream	SCD	c2a85a63-793f-4354-80a7-c475ae7bdfb5	5
203088	ketoconazole 2 % Topical Cream	SY	4f08caf2-a57c-4146-9289-532711bbdbcd	5
203088	ketoconazole 2 % Topical Cream	SY	c2a85a63-793f-4354-80a7-c475ae7bdfb5	5
203088	ketoconazole 2 % Topical Cream	PSN	39b85d6a-9133-42e6-b7f8-58f045e9b9f0	4
203088	ketoconazole 20 MG/ML Topical Cream	SCD	39b85d6a-9133-42e6-b7f8-58f045e9b9f0	4
203088	ketoconazole 2 % Topical Cream	SY	39b85d6a-9133-42e6-b7f8-58f045e9b9f0	4
203088	ketoconazole 2 % Topical Cream	PSN	836ebf14-fb11-45c3-9e0c-db1bebcd0f5b	1
203088	ketoconazole 2 % Topical Cream	PSN	c23a27a2-e2e5-4a93-a96a-1f0248286f43	1
203088	ketoconazole 2 % Topical Cream	PSN	1c4235cc-931c-3a51-e063-6394a90a9017	1
203088	ketoconazole 2 % Topical Cream	PSN	ebd520d0-8069-490f-a0d7-356d1e7c3dfd	1
198886	urea 20 % Topical Cream	PSN	ebd520d0-8069-490f-a0d7-356d1e7c3dfd	1
203088	ketoconazole 20 MG/ML Topical Cream	SCD	c23a27a2-e2e5-4a93-a96a-1f0248286f43	1
203088	ketoconazole 20 MG/ML Topical Cream	SCD	836ebf14-fb11-45c3-9e0c-db1bebcd0f5b	1
203088	ketoconazole 20 MG/ML Topical Cream	SCD	ebd520d0-8069-490f-a0d7-356d1e7c3dfd	1
203088	ketoconazole 20 MG/ML Topical Cream	SCD	1c4235cc-931c-3a51-e063-6394a90a9017	1
198886	urea 200 MG/ML Topical Cream	SCD	ebd520d0-8069-490f-a0d7-356d1e7c3dfd	1
203088	ketoconazole 2 % Topical Cream	SY	c23a27a2-e2e5-4a93-a96a-1f0248286f43	1
203088	ketoconazole 2 % Topical Cream	SY	836ebf14-fb11-45c3-9e0c-db1bebcd0f5b	1
203088	ketoconazole 2 % Topical Cream	SY	ebd520d0-8069-490f-a0d7-356d1e7c3dfd	1
203088	ketoconazole 2 % Topical Cream	SY	1c4235cc-931c-3a51-e063-6394a90a9017	1
198886	urea 17 GM in 85 GM Topical Cream	SY	ebd520d0-8069-490f-a0d7-356d1e7c3dfd	1
198886	urea 20 % Topical Cream	SY	ebd520d0-8069-490f-a0d7-356d1e7c3dfd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-1298-1	51672129801	1 TUBE in 1 CARTON (51672-1298-1) / 15 g in 1 TUBE	1 tube	2002-12-18	0000-00-00	No	No	Current
51672-1298-2	51672129802	1 TUBE in 1 CARTON (51672-1298-2) / 30 g in 1 TUBE	1 tube	2002-12-18	0000-00-00	No	No	Current
51672-1298-3	51672129803	1 TUBE in 1 CARTON (51672-1298-3) / 60 g in 1 TUBE	1 tube	2002-12-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketoconazole Cream, 2%	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-07-07	HUMAN PRESCRIPTION DRUG LABEL	4
Ketoconazole Cream, 2%	NuCare Pharmaceuticals,Inc.	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL	6
Ketoconazole Cream, 2%	Redpharm Drug	2024-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
Ketoconazole Cream, 2%	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Podiatrole	V2 Pharma, LLC	2023-01-06	HUMAN PRESCRIPTION DRUG LABEL	1
Ketoconazole Cream, 2%	Preferred Pharmaceuticals, Inc.	2022-07-08	HUMAN PRESCRIPTION DRUG LABEL	7
Ketoconazole Cream, 2%	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	5
Ketoconazole Cream, 2%	REMEDYREPACK INC.	2022-02-21	HUMAN PRESCRIPTION DRUG LABEL	4
Ketoconazole Cream, 2%	NuCare Pharmaceuticals,Inc.	2021-07-28	HUMAN PRESCRIPTION DRUG LABEL	3
Ketoconazole Cream, 2%	A-S Medication Solutions	2021-06-16	HUMAN PRESCRIPTION DRUG LABEL	7
Ketoconazole Cream, 2%	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	11
Ketoconazole Cream, 2%	NuCare Pharmaceuticals,Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	3
Ketoconazole Cream, 2%	NuCare Pharmaceuticals,Inc.	2017-08-31	HUMAN PRESCRIPTION DRUG LABEL	1
Ketoconazole Cream, 2%	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-02-16	HUMAN PRESCRIPTION DRUG LABEL	1
Ketoconazole Cream, 2%	Rebel Distributors Corp	2011-01-17	HUMAN PRESCRIPTION DRUG LABEL	1