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Active ingredient

Octreotide

35 finished FDA listings contain Octreotide as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
OCTREOTIDE, OCTREOTIDE ACETATE
Dosage forms
Capsule, Delayed Release, Injection, Injection, Solution
Routes
Intravenous, Oral, Subcutaneous
Manufacturers / labelers
12
Strengths listed
100 ug/ml · 1000 ug/ml · 2.5 mg/ml · 20 mg/1 · 200 ug/ml · 50 ug/ml · 500 ug/ml
Brand names in FDA listings
Bynfezia Pen, Mycapssa, Octreotide, Sandostatin

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7617

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 019667NOVARTIS1988-10-213
ANDA 076313WEST-WARD PHARMS INT2005-03-283
ANDA 076330WEST-WARD PHARMS INT2005-04-082
ANDA 075957MEITHEAL2005-10-033
ANDA 077457FRESENIUS KABI USA2006-02-104
ANDA 077450FRESENIUS KABI USA2006-02-102
ANDA 079198MYLAN INSTITUTIONAL2011-02-103
ANDA 203765HERITAGE2018-09-072
ANDA 204669HERITAGE2018-12-273
NDA 208232CHIESI2020-06-262
ANDA 216807GLAND2023-06-132
ANDA 216839GLAND2023-06-224
ANDA 217860QUAGEN2024-05-021
NDA 213224SUN PHARM2024-09-271

Official labeling on DailyMed

Showing the 12 most recent of 14 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.