octreotide acetate

Generic: octreotide acetate

Labeler: meitheal pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

octreotide acetate 50 ug/mL

Manufacturer
Meitheal Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 71288-566
Product ID 71288-566_a12a7206-6077-4b61-a038-4aae1170b387
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075957
Listing Expiration 2026-12-31
Marketing Start 2025-02-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288566
Hyphenated Format 71288-566

Supplemental Identifiers

RxCUI
312068 312069 312070
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 ANDA075957 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 50 ug/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-566-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-566-01)
source: ndc

Packages (1)

71288-566-02 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-566-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-566-01)

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": "a12a7206-6077-4b61-a038-4aae1170b387", "openfda": {"unii": ["75R0U2568I"], "rxcui": ["312068", "312069", "312070"], "spl_set_id": ["01962c67-e551-47b6-a276-e1ae1860d2a4"], "manufacturer_name": ["Meitheal Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-566-02)  / 1 mL in 1 VIAL, SINGLE-DOSE (71288-566-01)", "package_ndc": "71288-566-02", "marketing_start_date": "20250228"}], "brand_name": "Octreotide Acetate", "product_id": "71288-566_a12a7206-6077-4b61-a038-4aae1170b387", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "71288-566", "generic_name": "Octreotide Acetate", "labeler_name": "Meitheal Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Octreotide Acetate", "active_ingredients": [{"name": "OCTREOTIDE ACETATE", "strength": "50 ug/mL"}], "application_number": "ANDA075957", "marketing_category": "ANDA", "marketing_start_date": "20250228", "listing_expiration_date": "20261231"}