Ciclopirox

Product NDC: 68071-1524
11-digit product format: 680711524
Labeler code: 68071
Product ID: 68071-1524_bb0522e7-6d55-f790-e053-2995a90a5b04
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciclopirox
Dosage form: SOLUTION
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA077623
Marketing category: ANDA
Marketing start: 2007-09-19
Marketing end: 0000-00-00
Substance: CICLOPIROX
Active strength: 80 mg/mL
Pharmacologic classes: Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-1524		D	Discontinued by firm		2026-08-03
excluded package	package	68071-1524	68071-1524-6	D	Discontinued by firm		2026-08-03

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1524-6	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1524-6	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1524-6	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1524-6	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1524-6	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1524-6	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1524-6	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-1524-6	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-1524-6	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-1524-6	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-1524-6	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1524-6	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1524-6	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1524-6	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1524-6	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A077623-001	CICLOPIROX	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077623-001	AT

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077623-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077623-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077623-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077623-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077623-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077623-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077623-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077623-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077623-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077623-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077623-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077623-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077623-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077623-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077623-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077623-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077623-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077623-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077623-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077623-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077623-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077623-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077623-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077623-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077623-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077623-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077623-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077623-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077623-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077623-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077623-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077623-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077623-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077623-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077623-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077623-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077623-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077623-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077623-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077623-001	AT	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-07-17	Ciclopirox Topical Solution, 8%
2023-01-30	Ciclopirox Topical Solution, 8%
2021-02-10	Ciclopirox Topical Solution, 8%
2021-01-29	Ciclopirox Topical Solution, 8%

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
Ciclopirox	CICLOPIROX	Bryant Ranch Prepack	d7e22682-1485-47e5-b6ae-94534bd3d889	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077623 application number: ANDA077623
Ciclopirox	CICLOPIROX	Preferred Pharmaceuticals, Inc.	efcd78c0-2426-4fcc-a1c8-527e4e6f99d3	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077623 application number: ANDA077623
Ciclopirox	CICLOPIROX	Bryant Ranch Prepack	9c7d1fd9-71dd-4bbb-aed2-7db5cffa8b5a	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077623 application number: ANDA077623
Ciclopirox	CICLOPIROX	Padagis Israel Pharmaceuticals Ltd	02f46b6e-b424-4210-83bf-e79618df4344	2023-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077623 application number: ANDA077623

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19W019ZDRJ	CICLOPIROX	29342-05-0	CICLOPIROX

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1524-6	68071152406	6.6 mL in 1 BOX (68071-1524-6)	6.6 ml	2017-08-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciclopirox Topical Solution, 8%	NuCare Pharmaceuticals,Inc.	2021-02-10	HUMAN PRESCRIPTION DRUG LABEL	2