CICLOPIROX OLAMINE

Product NDC: 69315-309
11-digit product format: 693150309
Labeler code: 69315
Product ID: 69315-309_232bf664-5638-47a3-a464-440467039140
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CICLOPIROX OLAMINE
Dosage form: SUSPENSION
Route: TOPICAL
Labeler: Leading Pharma, LLC
Application: NDA019824
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-12-01
Marketing end: 0000-00-00
Substance: CICLOPIROX OLAMINE
Active strength: 8 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: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69315-309		I	Inactivated by FDA	2026-08-17
excluded package	package	69315-309	69315-309-30	I	Inactivated by FDA	2026-08-17
excluded package	package	69315-309	69315-309-60	I	Inactivated by FDA	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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69315-309-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69315-309-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69315-309-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69315-309-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69315-309-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69315-309-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69315-309-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69315-309-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69315-309-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69315-309-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69315-309-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69315-309-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69315-309-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69315-309-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69315-309-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69315-309-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69315-309-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69315-309-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69315-309-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69315-309-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69315-309-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69315-309-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69315-309-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69315-309-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69315-309-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69315-309-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69315-309-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69315-309-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69315-309-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69315-309-30	`1332a3947898…`	`d4bfe170f9cd…`

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
N019824-001	LOPROX	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019824-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019824-001	LOPROX	0.77%	SUSPENSION / TOPICAL	AB	RLD, RS	1988-12-30	`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	N019824-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019824-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019824-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019824-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019824-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019824-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019824-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019824-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019824-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019824-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019824-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019824-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019824-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019824-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019824-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019824-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019824-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019824-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019824-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019824-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019824-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019824-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019824-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019824-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019824-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019824-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019824-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019824-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019824-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019824-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019824-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019824-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019824-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019824-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019824-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019824-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019824-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019824-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019824-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019824-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69315-309-30	2023-07-28	C162847	48780-1	0191ceaa-6c13-198a-e063-dbdaa90aec3e	Ciclopirox Topical Suspension, USP 0.77% For Topical Use Only Not for use in eyes Rx Only
69315-309-60	2023-07-28	C162847	48780-1	0191ceaa-6c13-198a-e063-dbdaa90aec3e	Ciclopirox Topical Suspension, USP 0.77% For Topical Use Only Not for use in eyes Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69315-309-30	CICLOPIROX OLAMINE	30 mL in 1 BOTTLE	SUSPENSION	30		2
69315-309-60	CICLOPIROX OLAMINE	60 mL in 1 BOTTLE	SUSPENSION	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-309-30	ML - Milliliter	69315-309	43179261-c9bc-400c-8ad0-2c6fadcf687f	1	2019-04-11
69315-309-60	ML - Milliliter	69315-309	fa7bc610-e028-44dc-bf62-d80864436d7e	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69315-309	CICLOPIROX OLAMINE SUSPENSION [LEADING PHARMA, LLC]	2	Legacy NDC, 2 package rows	20201218_370ab878-2753-435f-ae06-67ec9f9502e1.zip

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
309290	ciclopirox 0.77 % Topical Lotion	PSN	370ab878-2753-435f-ae06-67ec9f9502e1	2
309290	ciclopirox 7.7 MG/ML Topical Lotion	SCD	370ab878-2753-435f-ae06-67ec9f9502e1	2
309290	ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical Lotion	SY	370ab878-2753-435f-ae06-67ec9f9502e1	2
309290	ciclopirox 0.77 % Topical Lotion	SY	370ab878-2753-435f-ae06-67ec9f9502e1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69315-309-30	69315030930	30 mL in 1 BOTTLE (69315-309-30)	30 ml	2019-02-25	0000-00-00	No	No	Current
69315-309-60	69315030960	60 mL in 1 BOTTLE (69315-309-60)	60 ml	2019-02-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CICLOPIROX OLAMINE	Leading Pharma, LLC \| Medimetriks Pharamceuticals, Inc \| Teligent Pharma, Inc.	2020-04-30	HUMAN PRESCRIPTION DRUG LABEL	2