NDC 69097-950 - LEUPROLIDE ACETATE DEPOT

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 69097-950
Package NDCs from labels: 69097-950-32
Manufacturer: CIPLA USA INC. | GP PHARM SA
Effective date: 2024-08-27
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
LEUPROLIDE ACETATE DEPOT - CIPLA USA INC. \| GP PHARM SA	CIPLA USA INC. \| GP PHARM SA	2024-08-27	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69097-950-32	LEUPROLIDE ACETATE DEPOT	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	2 mL	22.5 mg in 2mL	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-950	LEUPROLIDE ACETATE DEPOT (LEUPROLIDE ACETATE) KIT [CIPLA USA INC.]	5	Unmatched	20240831_1563a30b-66e0-445d-ba3e-1ccd5218133f.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 6 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	ebd0839e-2e1d-4e0e-986c-19f1f5c76358	2022-09-15	Warnings	Exact identifier unii: 6OZP39ZG8H unii: K679OBS311
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80	Allergan, Inc.	aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0	2022-09-01	Warnings	Exact identifier unii: 6OZP39ZG8H unii: K679OBS311
REFRESH TEARS	CARBOXYMETHYLCELLULOSE SODIUM	Allergan, Inc.	329d1fe0-4432-4565-b7b1-65666bd86526	2022-06-30	Warnings	Exact identifier unii: K679OBS311
REFRESH Optive Mega-3	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	c5f2b3f2-2071-45bd-a010-67f848bc0233	2022-06-30	Warnings	Exact identifier unii: 6OZP39ZG8H unii: K679OBS311
REFRESH PLUS	CARBOXYMETHYLCELLULOSE SODIUM	Allergan, Inc.	0f6a4b4b-cde6-4518-84b5-ce997f1154a7	2022-06-28	Warnings	Exact identifier unii: K679OBS311

Reported adverse events (FAERS/openFDA)#

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