leuprolide acetate

Generic: leuprolide acetate

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leuprolide acetate
Generic Name leuprolide acetate
Labeler pai holdings, llc dba pai pharma
Dosage Form KIT
Routes
SUBCUTANEOUS
Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-2106
Product ID 0121-2106_b1a3e37b-0513-40cc-ab82-a6ec15dc533c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217957
Listing Expiration 2027-12-31
Marketing Start 2025-02-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01212106
Hyphenated Format 0121-2106

Supplemental Identifiers

RxCUI
545835 797544

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 (source: ndc)
Generic Name leuprolide acetate (source: ndc)
Application Number ANDA217957 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2.8 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (0121-2106-02) * 1 VIAL, MULTI-DOSE in 1 CARTON (0121-1053-02) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (0121-2105-01)
source: ndc

Packages (1)

0121-2106-02 1 KIT in 1 CARTON (0121-2106-02) * 1 VIAL, MULTI-DOSE in 1 CARTON (0121-1053-02) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (0121-2105-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

leuprolide acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "b1a3e37b-0513-40cc-ab82-a6ec15dc533c", "openfda": {"rxcui": ["545835", "797544"], "spl_set_id": ["19be0b7f-e68a-4547-9e49-b51b12821907"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (0121-2106-02)  *  1 VIAL, MULTI-DOSE in 1 CARTON (0121-1053-02)  / 2.8 mL in 1 VIAL, MULTI-DOSE *  1 mL in 1 PACKET (0121-2105-01)", "package_ndc": "0121-2106-02", "marketing_start_date": "20250201"}], "brand_name": "leuprolide acetate", "product_id": "0121-2106_b1a3e37b-0513-40cc-ab82-a6ec15dc533c", "dosage_form": "KIT", "product_ndc": "0121-2106", "generic_name": "leuprolide acetate", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "leuprolide acetate", "application_number": "ANDA217957", "marketing_category": "ANDA", "marketing_start_date": "20250201", "listing_expiration_date": "20271231"}