Ciclopirox Olamine

Product NDC: 63629-8627
11-digit product format: 636298627
Labeler code: 63629
Product ID: 63629-8627_c6d0d8c1-929a-4b96-a780-29212701185f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciclopirox Olamine
Dosage form: SUSPENSION
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA077676
Marketing category: ANDA
Marketing start: 2006-12-29
Substance: CICLOPIROX OLAMINE
Active strength: 7.7 mg/100mL
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 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
A077676-001	CICLOPIROX	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB		2006-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077676-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`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	A077676-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077676-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077676-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077676-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077676-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077676-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077676-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077676-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077676-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077676-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077676-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077676-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077676-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077676-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077676-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077676-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077676-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077676-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077676-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077676-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077676-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077676-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077676-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077676-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077676-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077676-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077676-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077676-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077676-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077676-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077676-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077676-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077676-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077676-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077676-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077676-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077676-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077676-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077676-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077676-001	AB	1	`cb3db0bc1861…`

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/100mL

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
29c638cd-b6cb-4e17-8cb3-636253a2e47c	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
63629-8627-1	Ciclopirox Olamine	60 mL in 1 BOTTLE	SUSPENSION	60		104
63629-8627-1	Ciclopirox Olamine	1 in 1 CARTON	SUSPENSION	1		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8627-1	ML - Milliliter	63629-8627	4e211b41-d77c-45ad-a261-33768a9a5e13	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8627	CICLOPIROX OLAMINE SUSPENSION [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 2 package rows	20250216_29c638cd-b6cb-4e17-8cb3-636253a2e47c.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 · 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	835a6370-f331-4b15-b6fa-beafe027f187	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	9130e3c7-566b-411b-b54d-c894e9094b5b	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676
Ciclopirox Olamine	CICLOPIROX OLAMINE	Padagis Israel Pharmaceuticals Ltd	eadbd29d-5990-4987-833f-40cd0b2d2868	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	29c638cd-b6cb-4e17-8cb3-636253a2e47c	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676 ndc (product): 63629-8627
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	246585a0-e53e-4f54-8f8b-76536011ab23	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	399fd2d5-f5a2-4bce-ad4e-ce70060a14b0	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8627-1	63629862701	1 BOTTLE in 1 CARTON (63629-8627-1) / 60 mL in 1 BOTTLE	1 bottle	2006-12-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion)	Bryant Ranch Prepack	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	104