leuprolide acetate depot

Generic: leuprolide acetate

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name leuprolide acetate depot
Generic Name leuprolide acetate
Labeler cipla usa inc.
Dosage Form KIT
Manufacturer
CIPLA USA INC.

Identifiers & Regulatory

Product NDC 69097-909
Product ID 69097-909_15d87847-b4c3-48bc-8c40-d8fc63fcb1b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205054
Listing Expiration 2026-12-31
Marketing Start 2022-07-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097909
Hyphenated Format 69097-909

Supplemental Identifiers

RxCUI
2606516
UPC
0369097950323 0369097960315

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name leuprolide acetate depot (source: ndc)
Generic Name leuprolide acetate (source: ndc)
Application Number NDA205054 (source: ndc)

Resolved Composition

Strengths
  • 22.5 mg
  • 2 ml
  • 0.8 %
source: label
Packaging
  • 1 KIT in 1 CARTON (69097-909-50) * 2 mL in 1 VIAL, SINGLE-DOSE (69097-950-32) * 2 mL in 1 SYRINGE (69097-960-31)
source: ndc

Packages (1)

69097-909-50 1 KIT in 1 CARTON (69097-909-50) * 2 mL in 1 VIAL, SINGLE-DOSE (69097-950-32) * 2 mL in 1 SYRINGE (69097-960-31)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

LEUPROLIDE ACETATE DEPOT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "15d87847-b4c3-48bc-8c40-d8fc63fcb1b0", "openfda": {"upc": ["0369097950323", "0369097960315"], "rxcui": ["2606516"], "spl_set_id": ["1563a30b-66e0-445d-ba3e-1ccd5218133f"], "manufacturer_name": ["CIPLA USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (69097-909-50)  *  2 mL in 1 VIAL, SINGLE-DOSE (69097-950-32)  *  2 mL in 1 SYRINGE (69097-960-31)", "package_ndc": "69097-909-50", "marketing_start_date": "20220715"}], "brand_name": "LEUPROLIDE ACETATE DEPOT", "product_id": "69097-909_15d87847-b4c3-48bc-8c40-d8fc63fcb1b0", "dosage_form": "KIT", "product_ndc": "69097-909", "generic_name": "leuprolide acetate", "labeler_name": "CIPLA USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEUPROLIDE ACETATE DEPOT", "application_number": "NDA205054", "marketing_category": "NDA", "marketing_start_date": "20220715", "listing_expiration_date": "20261231"}