eligard

Generic: leuprolide acetate

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

Drug Facts

Product Profile

Brand Name eligard
Generic Name leuprolide acetate
Labeler tolmar inc.
Dosage Form KIT
Routes
SUBCUTANEOUS
Manufacturer
TOLMAR Inc.

Identifiers & Regulatory

Product NDC 62935-223
Product ID 62935-223_2bea4c81-66a2-4817-9440-5f5da8dea04a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021379
Listing Expiration 2026-12-31
Marketing Start 2002-08-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62935223
Hyphenated Format 62935-223

Supplemental Identifiers

RxCUI
752884 752889 752894 752899 825325 825333 825334 825335

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 eligard (source: ndc)
Generic Name leuprolide acetate (source: ndc)
Application Number NDA021379 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 7.5 mg
  • 22.5 mg
  • 30 mg
  • 45 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (62935-223-05) * .375 mL in 1 SYRINGE (62935-221-04) * .375 mL in 1 SYRINGE (62935-224-05)
source: ndc

Packages (1)

62935-223-05 1 KIT in 1 CARTON (62935-223-05) * .375 mL in 1 SYRINGE (62935-221-04) * .375 mL in 1 SYRINGE (62935-224-05)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

ELIGARD ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "2bea4c81-66a2-4817-9440-5f5da8dea04a", "openfda": {"rxcui": ["752884", "752889", "752894", "752899", "825325", "825333", "825334", "825335"], "spl_set_id": ["b78d1919-9dee-44fa-90f9-e0a26d32481d"], "manufacturer_name": ["TOLMAR Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (62935-223-05)  *  .375 mL in 1 SYRINGE (62935-221-04)  *  .375 mL in 1 SYRINGE (62935-224-05)", "package_ndc": "62935-223-05", "marketing_start_date": "20020826"}], "brand_name": "ELIGARD", "product_id": "62935-223_2bea4c81-66a2-4817-9440-5f5da8dea04a", "dosage_form": "KIT", "product_ndc": "62935-223", "generic_name": "Leuprolide Acetate", "labeler_name": "TOLMAR Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELIGARD", "application_number": "NDA021379", "marketing_category": "NDA", "marketing_start_date": "20020826", "listing_expiration_date": "20261231"}