lutrate depot

Generic: leuprolide acetate

Labeler: avyxa pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lutrate depot
Generic Name leuprolide acetate
Labeler avyxa pharma, llc
Dosage Form KIT
Manufacturer
Avyxa Pharma, LLC

Identifiers & Regulatory

Product NDC 83831-134
Product ID 83831-134_d4332d30-8a83-4118-88bb-3c49851837b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205054
Listing Expiration 2026-12-31
Marketing Start 2025-03-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83831134
Hyphenated Format 83831-134

Supplemental Identifiers

RxCUI
2606516 2709448

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 lutrate 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 (83831-134-01) * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02)
source: ndc

Packages (1)

83831-134-01 1 KIT in 1 CARTON (83831-134-01) * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

LUTRATE DEPOT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "d4332d30-8a83-4118-88bb-3c49851837b6", "openfda": {"rxcui": ["2606516", "2709448"], "spl_set_id": ["3a6d1373-17d9-4289-b62f-d299ffe55831"], "manufacturer_name": ["Avyxa Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (83831-134-01)  *  2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22)  *  2 mL in 1 SYRINGE (83831-135-02)", "package_ndc": "83831-134-01", "marketing_start_date": "20250326"}], "brand_name": "LUTRATE DEPOT", "product_id": "83831-134_d4332d30-8a83-4118-88bb-3c49851837b6", "dosage_form": "KIT", "product_ndc": "83831-134", "generic_name": "leuprolide acetate", "labeler_name": "Avyxa Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LUTRATE DEPOT", "application_number": "NDA205054", "marketing_category": "NDA", "marketing_start_date": "20250326", "listing_expiration_date": "20261231"}