octreotide acetate

Generic: octreotide acetate

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name octreotide acetate
Generic Name octreotide acetate
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

octreotide acetate 50 ug/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-239
Product ID 67457-239_1bb19829-029a-4baf-a12c-ec04102dd79e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079198
Listing Expiration 2026-12-31
Marketing Start 2011-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457239
Hyphenated Format 67457-239

Supplemental Identifiers

RxCUI
1090558 1090559 1090560
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 ANDA079198 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 50 ug/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (67457-239-01) / 1 mL in 1 SYRINGE (67457-239-00)
source: ndc

Packages (1)

67457-239-01 10 SYRINGE in 1 CARTON (67457-239-01) / 1 mL in 1 SYRINGE (67457-239-00)

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": "1bb19829-029a-4baf-a12c-ec04102dd79e", "openfda": {"unii": ["75R0U2568I"], "rxcui": ["1090558", "1090559", "1090560"], "spl_set_id": ["2d78d5d1-77b2-4da1-98d4-d9c36e743ce2"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (67457-239-01)  / 1 mL in 1 SYRINGE (67457-239-00)", "package_ndc": "67457-239-01", "marketing_start_date": "20110401"}], "brand_name": "Octreotide Acetate", "product_id": "67457-239_1bb19829-029a-4baf-a12c-ec04102dd79e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "67457-239", "generic_name": "octreotide acetate", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Octreotide Acetate", "active_ingredients": [{"name": "OCTREOTIDE ACETATE", "strength": "50 ug/mL"}], "application_number": "ANDA079198", "marketing_category": "ANDA", "marketing_start_date": "20110401", "listing_expiration_date": "20261231"}