octreotide acetate

Generic: octreotide acetate

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name octreotide acetate
Generic Name octreotide acetate
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

octreotide acetate 50 ug/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-463
Product ID 25021-463_5e508c59-4170-441a-a94a-70b0bf28b8e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090834
Listing Expiration 2026-12-31
Marketing Start 2023-06-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021463
Hyphenated Format 25021-463

Supplemental Identifiers

RxCUI
312068 312069 312070 312071 314152
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 octreotide acetate (source: ndc)
Generic Name octreotide acetate (source: ndc)
Application Number ANDA090834 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 50 ug/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-463-01) / 1 mL in 1 VIAL
source: ndc

Packages (1)

25021-463-01 10 VIAL in 1 CARTON (25021-463-01) / 1 mL in 1 VIAL

Ingredients (1)

octreotide acetate (50 ug/mL)

Linked Drug Pages (1)

Octreotide Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "5e508c59-4170-441a-a94a-70b0bf28b8e4", "openfda": {"unii": ["75R0U2568I"], "rxcui": ["312068", "312069", "312070", "312071", "314152"], "spl_set_id": ["7ce2fc1e-7520-4d04-be45-2baba32ca24a"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-463-01)  / 1 mL in 1 VIAL", "package_ndc": "25021-463-01", "marketing_start_date": "20230615"}], "brand_name": "Octreotide Acetate", "product_id": "25021-463_5e508c59-4170-441a-a94a-70b0bf28b8e4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "25021-463", "generic_name": "octreotide acetate", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Octreotide Acetate", "active_ingredients": [{"name": "OCTREOTIDE ACETATE", "strength": "50 ug/mL"}], "application_number": "ANDA090834", "marketing_category": "ANDA", "marketing_start_date": "20230615", "listing_expiration_date": "20261231"}