bynfezia pen

Generic: octreotide acetate

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

Drug Facts

Product Profile

Brand Name bynfezia pen
Generic Name octreotide acetate
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

octreotide acetate 2.5 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-452
Product ID 62756-452_ee3c8bae-88f0-4b76-80af-98a3e3312585
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213224
Listing Expiration 2026-12-31
Marketing Start 2025-02-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62756452
Hyphenated Format 62756-452

Supplemental Identifiers

RxCUI
2360543 2360548
UNII
75R0U2568I

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 bynfezia pen (source: ndc)
Generic Name octreotide acetate (source: ndc)
Application Number NDA213224 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 CARTRIDGE in 1 CARTON (62756-452-36) / 2.8 mL in 1 CARTRIDGE
  • 2 CARTRIDGE in 1 CARTON (62756-452-37) / 2.8 mL in 1 CARTRIDGE
source: ndc

Packages (2)

62756-452-36 1 CARTRIDGE in 1 CARTON (62756-452-36) / 2.8 mL in 1 CARTRIDGE 62756-452-37 2 CARTRIDGE in 1 CARTON (62756-452-37) / 2.8 mL in 1 CARTRIDGE

Ingredients (1)

octreotide acetate (2.5 mg/mL)

Linked Drug Pages (1)

BYNFEZIA Pen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "ee3c8bae-88f0-4b76-80af-98a3e3312585", "openfda": {"unii": ["75R0U2568I"], "rxcui": ["2360543", "2360548"], "spl_set_id": ["20ed4e79-ad4c-426f-859d-83790c00439b"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTRIDGE in 1 CARTON (62756-452-36)  / 2.8 mL in 1 CARTRIDGE", "package_ndc": "62756-452-36", "marketing_start_date": "20250224"}, {"sample": false, "description": "2 CARTRIDGE in 1 CARTON (62756-452-37)  / 2.8 mL in 1 CARTRIDGE", "package_ndc": "62756-452-37", "marketing_start_date": "20250224"}], "brand_name": "BYNFEZIA Pen", "product_id": "62756-452_ee3c8bae-88f0-4b76-80af-98a3e3312585", "dosage_form": "INJECTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "62756-452", "generic_name": "octreotide acetate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BYNFEZIA Pen", "active_ingredients": [{"name": "OCTREOTIDE ACETATE", "strength": "2.5 mg/mL"}], "application_number": "NDA213224", "marketing_category": "NDA", "marketing_start_date": "20250224", "listing_expiration_date": "20261231"}