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
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.004MG/ML | Marketed (Rx) | AP | 9 | AP |
| injectable, injection | 0.015MG/ML | Discontinued | None | 0 | None |
| solution, nasal | 0.01% | Discontinued | None | 0 | None |
| spray, metered, nasal | 0.01MG/SPRAY | Discontinued | None | 2 | AB |
| tablet, oral | 0.1MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 0.2MG | Marketed (Rx) | AB | 5 | AB |
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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MEITHEAL PHARMACEUTICALS INC | 074888 | AP (A-rated, therapeutically equivalent) | October 15, 1997 | 0.004MG/ML |
| APOTEX INC | 076703 | AB (A-rated, therapeutically equivalent) | January 27, 2005 | 0.01MG/SPRAY |
| APOTEX INC | 077414 | AB (A-rated, therapeutically equivalent) | March 7, 2006 | 0.1MG, 0.2MG |
| HERITAGE PHARMA LABS INC | 207880 | AB (A-rated, therapeutically equivalent) | May 26, 2017 | 0.1MG, 0.2MG |
| SAGENT PHARMACEUTICALS INC | 204695 | AP (A-rated, therapeutically equivalent) | August 22, 2017 | 0.004MG/ML |
| SAGENT PHARMACEUTICALS INC | 204751 | AP (A-rated, therapeutically equivalent) | August 22, 2017 | 0.004MG/ML |
| ZYDUS PHARMACEUTICALS USA INC | 091345 | AB (A-rated, therapeutically equivalent) | October 3, 2017 | 0.01MG/SPRAY |
| ABHAI LLC | 210371 | AB (A-rated, therapeutically equivalent) | January 28, 2019 | 0.1MG, 0.2MG |
| NOVAST LABORATORIES LTD | 208357 | AB (A-rated, therapeutically equivalent) | June 6, 2019 | 0.1MG, 0.2MG |
| UBI PHARMA INC | 210218 | AP (A-rated, therapeutically equivalent) | February 14, 2020 | 0.004MG/ML |
| UBI PHARMA INC | 210223 | AP (A-rated, therapeutically equivalent) | September 17, 2020 | 0.004MG/ML |
| DR REDDYS LABORATORIES LTD | 215961 | AP (A-rated, therapeutically equivalent) | August 19, 2022 | 0.004MG/ML |
| GLAND PHARMA LTD | 216922 | AP (A-rated, therapeutically equivalent) | November 16, 2022 | 0.004MG/ML |
| GLAND PHARMA LTD | 216904 | AP (A-rated, therapeutically equivalent) | March 20, 2023 | 0.004MG/ML |
| AUROBINDO PHARMA LTD | 213095 | AB (A-rated, therapeutically equivalent) | March 21, 2024 | 0.1MG, 0.2MG |
| CAPLIN STERILES LTD | 219981 | AP (A-rated, therapeutically equivalent) | February 27, 2026 | 0.004MG/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.
More on Ddavp and Desmopressin Acetate
- What is Desmopressin Acetate used for?FDA label uses
- Is Desmopressin Acetate a controlled substance?Federal schedule
- Generic for DesmodaFDA Orange Book
- Generic for Ddavp (needs No Refrigeration)FDA Orange Book
- Generic for MinirinFDA Orange Book
- Factor VIII Activators listFDA drug class
- Vasopressin Analogs listFDA drug class
- NDC 55566-2200Ddavp NDC record
- NDC 55566-2300Ddavp NDC record
- NDC 55566-2600Ddavp NDC record