fensolvi

Generic: leuprolide acetate

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

Drug Facts

Product Profile

Brand Name fensolvi
Generic Name leuprolide acetate
Labeler tolmar inc.
Dosage Form KIT
Manufacturer
TOLMAR Inc.

Identifiers & Regulatory

Product NDC 62935-153
Product ID 62935-153_eeda0531-099b-4b55-b287-8c534c3bb5f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213150
Listing Expiration 2026-12-31
Marketing Start 2020-06-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62935153
Hyphenated Format 62935-153

Supplemental Identifiers

RxCUI
752884 2371773

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 fensolvi (source: ndc)
Generic Name leuprolide acetate (source: ndc)
Application Number NDA213150 (source: ndc)

Resolved Composition

Strengths
  • 45 mg
  • 18 g
source: label
Packaging
  • 1 KIT in 1 CARTON (62935-153-50) * .375 mL in 1 SYRINGE (62935-154-50) * .375 mL in 1 SYRINGE (62935-155-40)
source: ndc

Packages (1)

62935-153-50 1 KIT in 1 CARTON (62935-153-50) * .375 mL in 1 SYRINGE (62935-154-50) * .375 mL in 1 SYRINGE (62935-155-40)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Fensolvi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "eeda0531-099b-4b55-b287-8c534c3bb5f0", "openfda": {"rxcui": ["752884", "2371773"], "spl_set_id": ["dfb6e01c-f138-471d-bf5b-2be38247e3f0"], "manufacturer_name": ["TOLMAR Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (62935-153-50)  *  .375 mL in 1 SYRINGE (62935-154-50)  *  .375 mL in 1 SYRINGE (62935-155-40)", "package_ndc": "62935-153-50", "marketing_start_date": "20200603"}], "brand_name": "Fensolvi", "product_id": "62935-153_eeda0531-099b-4b55-b287-8c534c3bb5f0", "dosage_form": "KIT", "product_ndc": "62935-153", "generic_name": "Leuprolide Acetate", "labeler_name": "TOLMAR Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fensolvi", "application_number": "NDA213150", "marketing_category": "NDA", "marketing_start_date": "20200603", "listing_expiration_date": "20261231"}