leuprolide acetate

Generic: leuprolide acetate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leuprolide acetate
Generic Name leuprolide acetate
Labeler sun pharmaceutical industries, inc.
Dosage Form KIT
Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-936
Product ID 47335-936_a8e522f1-b44f-459c-9eaf-e4cc6f4f6864
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078885
Listing Expiration 2026-12-31
Marketing Start 2014-12-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335936
Hyphenated Format 47335-936

Supplemental Identifiers

RxCUI
545835 797544
UPC
0347335936407

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 ANDA078885 (source: ndc)

Resolved Composition

Strengths
  • 2.8 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (47335-936-40) * 1 VIAL, MULTI-DOSE in 1 CARTON / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET
source: ndc

Packages (1)

47335-936-40 1 KIT in 1 CARTON (47335-936-40) * 1 VIAL, MULTI-DOSE in 1 CARTON / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET

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 
{"spl_id": "a8e522f1-b44f-459c-9eaf-e4cc6f4f6864", "openfda": {"upc": ["0347335936407"], "rxcui": ["545835", "797544"], "spl_set_id": ["a3b01473-30c7-4945-bd60-2484221aaaad"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (47335-936-40)  *  1 VIAL, MULTI-DOSE in 1 CARTON / 2.8 mL in 1 VIAL, MULTI-DOSE *  1 mL in 1 PACKET", "package_ndc": "47335-936-40", "marketing_start_date": "20141215"}], "brand_name": "leuprolide acetate", "product_id": "47335-936_a8e522f1-b44f-459c-9eaf-e4cc6f4f6864", "dosage_form": "KIT", "product_ndc": "47335-936", "generic_name": "leuprolide acetate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "leuprolide acetate", "application_number": "ANDA078885", "marketing_category": "ANDA", "marketing_start_date": "20141215", "listing_expiration_date": "20261231"}