Ciclopirox olamine

Product NDC: 71335-2865
11-digit product format: 713352865
Labeler code: 71335
Product ID: 71335-2865_c777ce05-5026-460d-964f-b6b3faaf781d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciclopirox olamine
Dosage form: CREAM
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA077364
Marketing category: ANDA
Marketing start: 2006-07-19
Substance: CICLOPIROX OLAMINE
Active strength: 7.7 mg/g
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: 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
A077364-001	CICLOPIROX	CICLOPIROX	0.77%	CREAM / TOPICAL	AB		2006-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077364-001	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	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`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	A077364-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077364-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077364-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077364-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077364-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077364-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077364-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077364-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077364-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077364-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077364-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077364-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077364-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077364-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077364-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077364-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077364-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077364-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077364-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077364-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077364-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077364-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077364-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077364-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077364-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077364-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077364-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077364-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077364-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077364-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077364-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077364-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077364-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077364-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077364-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077364-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077364-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077364-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077364-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077364-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CICLOPIROX OLAMINE	7.7 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
50MD4SB4AP	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309289	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
43a7cab8-7921-43bd-8bfa-a9b96f97c94b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d24c6245-86b5-4444-bc75-c1ac73ab3016	Product name	1	20180612
c7015f08-288e-4cfa-93b5-f4959a4814ae	Product name	1	20150324
3f974526-143f-9d19-ee0c-98eeee0cdc3f	Product name	1	20140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-2865-1	Ciclopirox olamine	1 in 1 CARTON	CREAM	1		100
71335-2865-1	Ciclopirox olamine	15 g in 1 TUBE	CREAM	15		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2865-1	GM - Gram	71335-2865	9b47474a-4561-494e-8a3e-9492025e8e31	1	2025-12-16

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
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	6d02fb24-9736-4fe3-b909-1b2172aa2773	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364
Ciclopirox olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	74fda3b8-d1f0-4ade-a92a-286f3874f292	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	aa326ade-ff55-4355-b6c7-205d6d88d0a3	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364
Ciclopirox olamine	CICLOPIROX OLAMINE	Padagis Israel Pharmaceuticals Ltd	1a74ed86-997a-4b86-b54a-b2b2c94e8abb	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364
Ciclopirox olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	43a7cab8-7921-43bd-8bfa-a9b96f97c94b	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364 ndc (product): 71335-2865
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	81e31568-6d87-4d0b-ba52-d2794a7cb023	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
50MD4SB4AP	CICLOPIROX OLAMINE	41621-49-2	CICLOPIROX OLAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309289	ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical Cream	PSN	43a7cab8-7921-43bd-8bfa-a9b96f97c94b	100
309289	ciclopirox 7.7 MG/ML Topical Cream	SCD	43a7cab8-7921-43bd-8bfa-a9b96f97c94b	100
309289	ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical Cream	SY	43a7cab8-7921-43bd-8bfa-a9b96f97c94b	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2865-1	71335286501	1 TUBE in 1 CARTON (71335-2865-1) / 15 g in 1 TUBE	1 tube	2025-10-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciclopirox Olamine Cream USP, 0.77%	Bryant Ranch Prepack	2025-10-24	HUMAN PRESCRIPTION DRUG LABEL	100