lanreotide acetate

Generic: lanreotide acetate

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

Drug Facts

Product Profile

Brand Name lanreotide acetate
Generic Name lanreotide acetate
Labeler cipla usa inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

lanreotide acetate 60 mg/.2mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-880
Product ID 69097-880_fd205110-15eb-4707-82b2-185e5bbf616b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215395
Listing Expiration 2026-12-31
Marketing Start 2021-12-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097880
Hyphenated Format 69097-880

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 NDA215395 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/.2mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (69097-880-67) / .2 mL in 1 SYRINGE
source: ndc

Packages (1)

69097-880-67 1 SYRINGE in 1 CARTON (69097-880-67) / .2 mL in 1 SYRINGE

Ingredients (1)

lanreotide acetate (60 mg/.2mL)

Linked Drug Pages (1)

Lanreotide Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "fd205110-15eb-4707-82b2-185e5bbf616b", "openfda": {"unii": ["IEU56G3J9C"], "rxcui": ["749811", "749814", "749817"], "spl_set_id": ["11da176a-99bc-4ada-8b3f-6bd2b37a6313"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (69097-880-67)  / .2 mL in 1 SYRINGE", "package_ndc": "69097-880-67", "marketing_start_date": "20211224"}], "brand_name": "Lanreotide Acetate", "product_id": "69097-880_fd205110-15eb-4707-82b2-185e5bbf616b", "dosage_form": "INJECTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "69097-880", "generic_name": "lanreotide acetate", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lanreotide Acetate", "active_ingredients": [{"name": "LANREOTIDE ACETATE", "strength": "60 mg/.2mL"}], "application_number": "NDA215395", "marketing_category": "NDA", "marketing_start_date": "20211224", "listing_expiration_date": "20261231"}