Nizoral

Product NDC: 55505-196
Requested package NDC: 55505-196-64
11-digit product format: 555050196
Labeler code: 55505
Product ID: 55505-196_443a0d0c-3098-4c35-97f8-8d01a7b3c83a
Type: HUMAN OTC DRUG
Nonproprietary name: Ketoconazole
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Kramer Laboratories
Application: NDA020310
Marketing category: NDA
Marketing start: 2022-06-16
Substance: KETOCONAZOLE
Active strength: 10 mg/mL
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: 2027-12-31
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	55505-196	55505-196-64	D	Discontinued by firm		2026-08-11

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
N020310-001	NIZORAL ANTI-DANDRUFF	KETOCONAZOLE	1%	SHAMPOO / TOPICAL		RLD, RS	1997-10-10

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nizoral
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOCONAZOLE	10 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
240812	Internal RxNorm lookup
608844	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
a17b7424-ee7e-4fcc-b6b3-0904932ae319	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
55505-196-33	Nizoral	1 in 1 CARTON	SHAMPOO	1	7
55505-196-33	Nizoral	125 mL in 1 BOTTLE	SHAMPOO	125	7
55505-196-40	Nizoral	200 mL in 1 BOTTLE	SHAMPOO	200	7
55505-196-40	Nizoral	1 in 1 CARTON	SHAMPOO	1	7
55505-196-47	Nizoral	4 mL in 1 PACKET	SHAMPOO	4	7
55505-196-57	Nizoral	200 mL in 1 BOTTLE	SHAMPOO	200	7
55505-196-57	Nizoral	2 in 1 CARTON	SHAMPOO	2	7
55505-196-64	Nizoral	325 mL in 1 BOTTLE	SHAMPOO	325	7
55505-196-64	Nizoral	1 in 1 CARTON	SHAMPOO	1	7
55505-196-65	Nizoral	1 in 1 CARTON	SHAMPOO	1	7
55505-196-65	Nizoral	400 mL in 1 CARTON	SHAMPOO	400	7
55505-196-68	Nizoral	3 in 1 CARTON	SHAMPOO	3	7
55505-196-68	Nizoral	200 mL in 1 BOTTLE	SHAMPOO	200	7
55505-196-72	Nizoral	2 in 1 CARTON	SHAMPOO	2	7
55505-196-72	Nizoral	325 mL in 1 BOTTLE	SHAMPOO	325	7
55505-196-84	Nizoral	400 mL in 1 BOTTLE	SHAMPOO	400	7
55505-196-84	Nizoral	2 in 1 CARTON	SHAMPOO	2	7
55505-196-85	Nizoral	1 in 1 CARTON	SHAMPOO	1	7
55505-196-85	Nizoral	562 mL in 1 BOTTLE	SHAMPOO	562	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55505-196	NIZORAL (KETOCONAZOLE) SHAMPOO [KRAMER LABORATORIES]	5	Current NDC, Legacy NDC, 19 package rows	20250101_a17b7424-ee7e-4fcc-b6b3-0904932ae319.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nizoral	KETOCONAZOLE	Kramer Laboratories	a17b7424-ee7e-4fcc-b6b3-0904932ae319	2026-03-17	Warnings	Exact identifier application applno (NDA): 020310 application number: NDA020310 ndc (package): 55505-196-64 ndc (product): 55505-196 ndc11 (package): 55505019664
Nizoral	KETOCONAZOLE	Kramer Laboratories	f5c8c5b4-49bd-4dc7-8c29-8f1317c6ef88	2025-08-21	Warnings	Exact identifier application applno (NDA): 020310 application number: NDA020310
Nizoral	KETOCONAZOLE	Kramer Laboratories	8dd6b2f1-f438-4be1-a6c4-4f6c8902dfb6	2025-07-11	Warnings	Exact identifier application applno (NDA): 020310 application number: NDA020310

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
240812	ketoconazole 1 % Medicated Shampoo	PSN	a17b7424-ee7e-4fcc-b6b3-0904932ae319	7
608844	Nizoral A-D 1 % Medicated Shampoo	PSN	a17b7424-ee7e-4fcc-b6b3-0904932ae319	7
608844	ketoconazole 10 MG/ML Medicated Shampoo [Nizoral]	SBD	a17b7424-ee7e-4fcc-b6b3-0904932ae319	7
240812	ketoconazole 10 MG/ML Medicated Shampoo	SCD	a17b7424-ee7e-4fcc-b6b3-0904932ae319	7
240812	ketoconazole 1 % Medicated Shampoo	SY	a17b7424-ee7e-4fcc-b6b3-0904932ae319	7
608844	Nizoral 1 % Medicated Shampoo	SY	a17b7424-ee7e-4fcc-b6b3-0904932ae319	7
608844	Nizoral 10 MG/ML Medicated Shampoo	SY	a17b7424-ee7e-4fcc-b6b3-0904932ae319	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55505-196-64	55505019664	1 BOTTLE in 1 CARTON (55505-196-64) > 325 mL in 1 BOTTLE	1 bottle	2022-06-16	0000-00-00	No	No	Current