octreotide

Generic: octreotide acetate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name octreotide
Generic Name octreotide acetate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

octreotide acetate 500 ug/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-377
Product ID 63323-377_02ac0091-573d-41ba-8b4d-5a1d42b89b2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077457
Listing Expiration 2026-12-31
Marketing Start 2006-03-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323377
Hyphenated Format 63323-377

Supplemental Identifiers

RxCUI
312069 312070 312071 314152
UPC
0363323378059 0363323376000 0363323379056 0363323377007
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 (source: ndc)
Generic Name octreotide acetate (source: ndc)
Application Number ANDA077457 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 500 ug/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-377-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-377-00)
source: ndc

Packages (1)

63323-377-01 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-377-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-377-00)

Ingredients (1)

octreotide acetate (500 ug/mL)

Linked Drug Pages (2)

Octreotide ndc-match (0.9) Octreotide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "02ac0091-573d-41ba-8b4d-5a1d42b89b2e", "openfda": {"upc": ["0363323378059", "0363323376000", "0363323379056", "0363323377007"], "unii": ["75R0U2568I"], "rxcui": ["312069", "312070", "312071", "314152"], "spl_set_id": ["f278f0d8-4062-420a-97c3-3a8b88253a08"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-377-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-377-00)", "package_ndc": "63323-377-01", "marketing_start_date": "20060314"}], "brand_name": "Octreotide", "product_id": "63323-377_02ac0091-573d-41ba-8b4d-5a1d42b89b2e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "63323-377", "generic_name": "OCTREOTIDE ACETATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Octreotide", "active_ingredients": [{"name": "OCTREOTIDE ACETATE", "strength": "500 ug/mL"}], "application_number": "ANDA077457", "marketing_category": "ANDA", "marketing_start_date": "20060314", "listing_expiration_date": "20261231"}