lanreotide acetate

Generic: lanreotide acetate

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lanreotide acetate
Generic Name lanreotide acetate
Labeler exelan pharmaceuticals, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

lanreotide acetate 90 mg/.3mL

Manufacturer
EXELAN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 76282-719
Product ID 76282-719_054af266-c850-45c8-b027-d810d7d5f0ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217193
Listing Expiration 2026-12-31
Marketing Start 2025-05-30

Pharmacologic Class

Classes
somatostatin analog [epc] somatostatin receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282719
Hyphenated Format 76282-719

Supplemental Identifiers

RxCUI
749811 749814 749817
UNII
IEU56G3J9C

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 lanreotide acetate (source: ndc)
Generic Name lanreotide acetate (source: ndc)
Application Number ANDA217193 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 90 mg/.3mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (76282-719-67) / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE
source: ndc

Packages (1)

76282-719-67 1 POUCH in 1 CARTON (76282-719-67) / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE

Ingredients (1)

lanreotide acetate (90 mg/.3mL)

Linked Drug Pages (1)

LANREOTIDE ACETATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "054af266-c850-45c8-b027-d810d7d5f0ae", "openfda": {"unii": ["IEU56G3J9C"], "rxcui": ["749811", "749814", "749817"], "spl_set_id": ["eec3c37e-83a7-4195-bccf-cd5973459eef"], "manufacturer_name": ["EXELAN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (76282-719-67)  / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE", "package_ndc": "76282-719-67", "marketing_start_date": "20250530"}], "brand_name": "LANREOTIDE ACETATE", "product_id": "76282-719_054af266-c850-45c8-b027-d810d7d5f0ae", "dosage_form": "INJECTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "76282-719", "generic_name": "LANREOTIDE ACETATE", "labeler_name": "EXELAN PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LANREOTIDE ACETATE", "active_ingredients": [{"name": "LANREOTIDE ACETATE", "strength": "90 mg/.3mL"}], "application_number": "ANDA217193", "marketing_category": "ANDA", "marketing_start_date": "20250530", "listing_expiration_date": "20261231"}