Cyclosporine/Chondroitin PF

Product NDC: 71384-514
Requested package NDC: 71384-514-05
11-digit product format: 713840514
Labeler code: 71384
Product ID: 71384-514_9e3fb384-3c93-a772-e053-2a95a90a6eba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclosporine/Chondroitin Sulfate PF
Dosage form: EMULSION
Route: OPHTHALMIC
Labeler: Imprimis NJOF, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2018-07-01
Marketing end: 0000-00-00
Substance: CYCLOSPORINE
Active strength: 1 mg/mL
Pharmacologic classes: Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71384-514	71384-514-05	I	Inactivated by FDA		2026-10-05

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 · 18 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1be408a0-e15a-4092-b35e-4e294e65196f	Product name	3	20240216
b3fdee3e-0c46-442f-aad5-aa71941d5621	Product name	1	20231023
78fb0708-fce5-decd-6611-5a9fbe3e3dec	Product name	3	20230327
54840517-000d-4fcb-b976-a6ddd102faa0	Product name	1	20220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633a	Product name	1	20181029
b1c0d609-8b97-06ee-2cd0-5652a4b1d019	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71384-514-05	2022-01-28	C162847	48780-1	9d75b9d0-d597-f424-e053-dadaa90a57ce	6ef02195-0ad6-0c27-e053-2991aa0aecb2
71384-514-05	2020-02-10	C162847	48780-1	9d75b9d0-d597-f424-e053-dadaa90a57ce	6ef02195-0ad6-0c27-e053-2991aa0aecb2
71384-514-05	2020-01-31	C162847	48780-1	9d75b9d0-d597-f424-e053-dadaa90a57ce	6ef02195-0ad6-0c27-e053-2991aa0aecb2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71384-514-05	Cyclosporine/Chondroitin PF	5.5 mL in 1 BOTTLE, DROPPER	EMULSION	5.5		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71384-514-05	ML - Milliliter	71384-514	398683af-eb3e-4e89-ae37-32501c41d80f	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71384-514	CYCLOSPORINE/CHONDROITIN PF (CYCLOSPORINE/CHONDROITIN SULFATE PF) EMULSION [IMPRIMIS NJOF, LLC]	2	Legacy NDC, 1 package rows	20200211_6ef02195-0ad6-0c27-e053-2991aa0aecb2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83HN0GTJ6D	CYCLOSPORINE	59865-13-3	CYCLOSPORINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71384-514-05	71384051405	5.5 mL in 1 BOTTLE, DROPPER (71384-514-05)	5.5 ml	2018-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclosporine/Chondroitin PF - Imprimis NJOF, LLC	Imprimis NJOF, LLC	2020-02-10	HUMAN PRESCRIPTION DRUG LABEL	2