Nizoral

Product NDC: 55505-191
Requested package NDC: 55505-191-33
11-digit product format: 555050191
Labeler code: 55505
Product ID: 55505-191_681ce4eb-f27d-443d-a6b1-1debb812678c
Type: HUMAN OTC DRUG
Nonproprietary name: Ketoconazole
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Kramer Laboratories
Application: NDA020310
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-01-07
Marketing end: 2021-08-01
Substance: KETOCONAZOLE
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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	55505-191	55505-191-33	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`caaa826d4ba7…`
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55505-191-40	ML - Milliliter	55505-191	fd884180-6a09-4c64-8b36-46031ea06bfb	1	2019-08-06

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55505-191-33	55505019133	125 mL in 1 BOTTLE (55505-191-33)	125 ml	2019-01-07	2021-08-01	No	No	Current