FDA Orange Book

Generic for Sandostatin

Sandostatin contains octreotide acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Sandostatin is octreotide acetate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

Run it in Rivvi

Map Sandostatin and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Sandostatin products in the Orange Book

Sandostatin products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, injection	EQ 0.05MG BASE/ML	Marketed (Rx)	AP	6	AP
injectable, injection	EQ 0.1MG BASE/ML	Marketed (Rx)	AP	7	AP
injectable, injection	EQ 0.2MG BASE/ML	Discontinued	None	6	AP
injectable, injection	EQ 0.5MG BASE/ML	Marketed (Rx)	AP	7	AP
injectable, injection	EQ 1MG BASE/ML	Discontinued	None	6	AP

NDA 019667, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic octreotide acetate

Approved generic versions of Sandostatin
Company	ANDA	TE code	Approved	Strengths
WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD	076313	AP (A-rated, therapeutically equivalent)	March 28, 2005	EQ 0.05MG BASE/ML, EQ 0.1MG BASE/ML, EQ 0.5MG BASE/ML
WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD	076330	AP (A-rated, therapeutically equivalent)	April 8, 2005	EQ 0.2MG BASE/ML, EQ 1MG BASE/ML
MEITHEAL PHARMACEUTICALS INC	075957	AP (A-rated, therapeutically equivalent)	October 3, 2005	EQ 0.05MG BASE/ML, EQ 0.1MG BASE/ML, EQ 0.5MG BASE/ML
MEITHEAL PHARMACEUTICALS INC	075959	AP (A-rated, therapeutically equivalent)	November 21, 2005	EQ 0.2MG BASE/ML, EQ 1MG BASE/ML
FRESENIUS KABI USA LLC	077457	AP (A-rated, therapeutically equivalent)	February 10, 2006	EQ 0.05MG BASE/ML, EQ 0.1MG BASE/ML, EQ 0.5MG BASE/ML
FRESENIUS KABI USA LLC	077450	AP (A-rated, therapeutically equivalent)	February 10, 2006	EQ 0.2MG BASE/ML, EQ 1MG BASE/ML
MYLAN INSTITUTIONAL LLC	079198	AP (A-rated, therapeutically equivalent)	February 10, 2011	EQ 0.05MG BASE/ML, EQ 0.1MG BASE/ML, EQ 0.5MG BASE/ML
SAGENT PHARMACEUTICALS INC	090834	AP (A-rated, therapeutically equivalent)	November 12, 2013	EQ 0.05MG BASE/ML, EQ 0.1MG BASE/ML, EQ 0.5MG BASE/ML
SAGENT PHARMACEUTICALS INC	091041	AP (A-rated, therapeutically equivalent)	November 12, 2013	EQ 0.2MG BASE/ML, EQ 1MG BASE/ML
HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC	203765	AP (A-rated, therapeutically equivalent)	September 7, 2018	EQ 0.2MG BASE/ML, EQ 1MG BASE/ML
HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC	204669	AP (A-rated, therapeutically equivalent)	December 27, 2018	EQ 0.05MG BASE/ML, EQ 0.1MG BASE/ML, EQ 0.5MG BASE/ML
GLAND PHARMA LTD	216807	AP (A-rated, therapeutically equivalent)	June 13, 2023	EQ 0.2MG BASE/ML, EQ 1MG BASE/ML
GLAND PHARMA LTD	216839	AP (A-rated, therapeutically equivalent)	June 22, 2023	EQ 0.1MG BASE/ML, EQ 0.5MG BASE/ML

Sandostatin NDC codes

Questions

Is there a generic for Sandostatin?

Yes. The generic name for Sandostatin is octreotide acetate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for Sandostatin?

The active ingredient in Sandostatin is octreotide acetate, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.