Ketoconazole

Product NDC: 51672-4026
Requested package NDC: 51672-4026-6
11-digit product format: 516724026
Labeler code: 51672
Product ID: 51672-4026_3dd44662-95fb-0d34-e063-6294a90a5fbc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA075319
Marketing category: ANDA
Marketing start: 1999-06-15
Substance: KETOCONAZOLE
Active strength: 200 mg/1
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51672-4026	51672-4026-6	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075319-001	KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075319-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075319-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	RS	1999-06-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075319-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075319-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075319-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075319-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075319-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075319-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075319-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075319-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075319-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075319-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075319-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075319-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075319-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075319-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075319-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075319-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075319-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075319-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075319-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075319-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075319-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075319-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075319-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075319-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075319-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075319-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075319-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075319-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075319-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075319-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075319-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075319-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075319-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075319-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075319-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075319-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075319-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075319-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075319-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075319-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOCONAZOLE	200 mg/1

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
197853	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
8ca815a8-bccb-4ee2-a042-922373329cae	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	SPL version
51672-4026-0	Ketoconazole	10 in 1 BLISTER PACK	TABLET	10	12
51672-4026-0	Ketoconazole	10 in 1 BOX	TABLET	10	12
51672-4026-1	Ketoconazole	100 in 1 BOTTLE	TABLET	100	12
51672-4026-2	Ketoconazole	500 in 1 BOTTLE	TABLET	500	12
51672-4026-6	Ketoconazole	30 in 1 BOTTLE	TABLET	30	12
51672-4026-8	Ketoconazole	3 in 1 BOX	TABLET	3	12
51672-4026-8	Ketoconazole	10 in 1 BLISTER PACK	TABLET	10	12
51672-4026-9	Ketoconazole	10 in 1 BLISTER PACK	TABLET	10	12
51672-4026-9	Ketoconazole	5 in 1 BOX	TABLET	5	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4026-1	EA - Each	51672-4026	a53b7fa1-98a3-49e6-9f13-07af603854d6	1	2012-07-24
51672-4026-6	EA - Each	51672-4026	12e5aaf9-13ce-432d-9378-bfee61a1e11f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
povidones	INACTIVE INGREDIENT	FZ989GH94E	KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	5
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
colloidal silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
povidone	INACTIVE INGREDIENT	FZ989GH94E	KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	KETOCONAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	4
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
povidones	INACTIVE INGREDIENT	FZ989GH94E	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	KETOCONAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
KETOCONAZOLE	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
KETOCONAZOLE	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
KETOCONAZOLE	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
KETOCONAZOLE	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	KETOCONAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	KETOCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	KETOCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4026	KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	11	Current NDC, Legacy NDC, 9 package rows	20240524_8ca815a8-bccb-4ee2-a042-922373329cae.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	4baebcab-a237-42c0-9183-6f447a44e371	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075319 application number: ANDA075319
Ketoconazole	KETOCONAZOLE	Golden State Medical Supply, Inc.	a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075319 application number: ANDA075319
Ketoconazole	KETOCONAZOLE	Sun Pharmaceutical Industries, Inc.	8ca815a8-bccb-4ee2-a042-922373329cae	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075319 application number: ANDA075319 ndc (package): 51672-4026-6 ndc (product): 51672-4026 ndc11 (package): 51672402606
Ketoconazole	KETOCONAZOLE	Direct_Rx	f5dc1e67-639f-5476-e053-2995a90a4210	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075319 application number: ANDA075319

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
197853	ketoconazole 200 MG Oral Tablet	PSN	a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7	13
197853	ketoconazole 200 MG Oral Tablet	SCD	a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7	13
197853	ketoconazole 200 MG Oral Tablet	PSN	8ca815a8-bccb-4ee2-a042-922373329cae	12
197853	ketoconazole 200 MG Oral Tablet	SCD	8ca815a8-bccb-4ee2-a042-922373329cae	12
197853	ketoconazole 200 MG Oral Tablet	PSN	4baebcab-a237-42c0-9183-6f447a44e371	11
197853	ketoconazole 200 MG Oral Tablet	SCD	4baebcab-a237-42c0-9183-6f447a44e371	11
197853	ketoconazole 200 MG Oral Tablet	PSN	f5dc1e67-639f-5476-e053-2995a90a4210	2
197853	ketoconazole 200 MG Oral Tablet	SCD	f5dc1e67-639f-5476-e053-2995a90a4210	2
197853	ketoconazole 200 MG Oral Tablet	PSN	092f1cea-edf2-4536-b378-34b28e281b83	1
197853	ketoconazole 200 MG Oral Tablet	PSN	e96fcf16-543e-4a02-9dac-afad20f79108	1
197853	ketoconazole 200 MG Oral Tablet	PSN	ec308fcf-ec39-43af-97e3-98aa8ab997f4	1
197853	ketoconazole 200 MG Oral Tablet	PSN	efbb79b0-5f43-7ada-e053-2995a90ae470	1
197853	ketoconazole 200 MG Oral Tablet	SCD	092f1cea-edf2-4536-b378-34b28e281b83	1
197853	ketoconazole 200 MG Oral Tablet	SCD	e96fcf16-543e-4a02-9dac-afad20f79108	1
197853	ketoconazole 200 MG Oral Tablet	SCD	ec308fcf-ec39-43af-97e3-98aa8ab997f4	1
197853	ketoconazole 200 MG Oral Tablet	SCD	efbb79b0-5f43-7ada-e053-2995a90ae470	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4026-6	51672402606	30 TABLET in 1 BOTTLE (51672-4026-6)	30 tablet	1999-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketoconazole Tablets USP, 200 MG	Bryant Ranch Prepack	2025-11-18	HUMAN PRESCRIPTION DRUG LABEL	11
Ketoconazole Tablets USP, 200 mg	Golden State Medical Supply, Inc.	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	13
Ketoconazole Tablets USP, 200 mg	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceutical Industries Ltd.	2025-09-02	HUMAN PRESCRIPTION DRUG LABEL	12
Ketoconazole	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Ketoconazole Tablets USP, 200 mg	REMEDYREPACK INC.	2024-06-04	HUMAN PRESCRIPTION DRUG LABEL	9
Ketoconazole Tablets USP, 200 MG	NuCare Pharmaceuticals,Inc.	2022-12-13	HUMAN PRESCRIPTION DRUG LABEL	1
Ketoconazole Tablets USP, 200 MG	PD-Rx Pharmaceuticals, Inc.	2021-12-09	HUMAN PRESCRIPTION DRUG LABEL	12
Ketoconazole Tablets USP, 200 MG	Preferred Pharmaceuticals, Inc.	2020-06-19	HUMAN PRESCRIPTION DRUG LABEL	7
Ketoconazole Tablets USP, 200 MG	NuCare Pharmaceuticals, Inc.	2017-07-24	HUMAN PRESCRIPTION DRUG LABEL	1
Ketoconazole Tablets USP, 200 MG	Aidarex Pharmaceuticals LLC	2014-01-05	HUMAN PRESCRIPTION DRUG LABEL	1
Ketoconazole - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-03-10	HUMAN PRESCRIPTION DRUG LABEL	1
KETOCONAZOLE TABLETS USP, 200 mg	Rebel Distributors Corp	2010-09-29	HUMAN PRESCRIPTION DRUG LABEL	1