FDA Orange Book

Generic for Ddavp

Ddavp contains desmopressin 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 Ddavp is desmopressin acetate. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 4 of the 6 Ddavp products the Orange Book lists.

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Ddavp products in the Orange Book

Ddavp products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection0.004MG/MLMarketed (Rx)AP9AP
injectable, injection0.015MG/MLDiscontinuedNone0None
solution, nasal0.01%DiscontinuedNone0None
spray, metered, nasal0.01MG/SPRAYDiscontinuedNone2AB
tablet, oral0.1MGMarketed (Rx)AB5AB
tablet, oral0.2MGMarketed (Rx)AB5AB

NDA 018938, 017922, 019955, held by J MOLNER HOLDINGS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic desmopressin acetate

Approved generic versions of Ddavp
CompanyANDATE codeApprovedStrengths
MEITHEAL PHARMACEUTICALS INC074888AP (A-rated, therapeutically equivalent)October 15, 19970.004MG/ML
APOTEX INC076703AB (A-rated, therapeutically equivalent)January 27, 20050.01MG/SPRAY
APOTEX INC077414AB (A-rated, therapeutically equivalent)March 7, 20060.1MG, 0.2MG
HERITAGE PHARMA LABS INC207880AB (A-rated, therapeutically equivalent)May 26, 20170.1MG, 0.2MG
SAGENT PHARMACEUTICALS INC204695AP (A-rated, therapeutically equivalent)August 22, 20170.004MG/ML
SAGENT PHARMACEUTICALS INC204751AP (A-rated, therapeutically equivalent)August 22, 20170.004MG/ML
ZYDUS PHARMACEUTICALS USA INC091345AB (A-rated, therapeutically equivalent)October 3, 20170.01MG/SPRAY
ABHAI LLC210371AB (A-rated, therapeutically equivalent)January 28, 20190.1MG, 0.2MG
NOVAST LABORATORIES LTD208357AB (A-rated, therapeutically equivalent)June 6, 20190.1MG, 0.2MG
UBI PHARMA INC210218AP (A-rated, therapeutically equivalent)February 14, 20200.004MG/ML
UBI PHARMA INC210223AP (A-rated, therapeutically equivalent)September 17, 20200.004MG/ML
DR REDDYS LABORATORIES LTD215961AP (A-rated, therapeutically equivalent)August 19, 20220.004MG/ML
GLAND PHARMA LTD216922AP (A-rated, therapeutically equivalent)November 16, 20220.004MG/ML
GLAND PHARMA LTD216904AP (A-rated, therapeutically equivalent)March 20, 20230.004MG/ML
AUROBINDO PHARMA LTD213095AB (A-rated, therapeutically equivalent)March 21, 20240.1MG, 0.2MG
CAPLIN STERILES LTD219981AP (A-rated, therapeutically equivalent)February 27, 20260.004MG/ML

Ddavp NDC codes

Questions

Is there a generic for Ddavp?

Yes. The generic name for Ddavp is desmopressin acetate. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 4 of the 6 Ddavp products the Orange Book lists.

What is the generic name for Ddavp?

The active ingredient in Ddavp is desmopressin 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.

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