octreotide acetate

Generic: octreotide acetate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name octreotide acetate
Generic Name octreotide acetate
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

octreotide acetate 100 ug/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-517
Product ID 68083-517_723308d0-ea28-4f3f-b993-0bc5cfe33cfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216839
Listing Expiration 2026-12-31
Marketing Start 2023-06-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083517
Hyphenated Format 68083-517

Supplemental Identifiers

RxCUI
312069 312070
UPC
0368083517106 0368083560102
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 ANDA216839 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-517-10) / 1 mL in 1 VIAL
source: ndc

Packages (1)

68083-517-10 10 VIAL in 1 CARTON (68083-517-10) / 1 mL in 1 VIAL

Ingredients (1)

octreotide acetate (100 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": "723308d0-ea28-4f3f-b993-0bc5cfe33cfe", "openfda": {"upc": ["0368083517106", "0368083560102"], "unii": ["75R0U2568I"], "rxcui": ["312069", "312070"], "spl_set_id": ["884e4287-a4d8-4a6e-8d99-dbe5e88875b9"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-517-10)  / 1 mL in 1 VIAL", "package_ndc": "68083-517-10", "marketing_start_date": "20230622"}], "brand_name": "Octreotide Acetate", "product_id": "68083-517_723308d0-ea28-4f3f-b993-0bc5cfe33cfe", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "68083-517", "generic_name": "Octreotide Acetate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Octreotide Acetate", "active_ingredients": [{"name": "OCTREOTIDE ACETATE", "strength": "100 ug/mL"}], "application_number": "ANDA216839", "marketing_category": "ANDA", "marketing_start_date": "20230622", "listing_expiration_date": "20261231"}