FDA Orange Book
Generic for Northera
Northera contains droxidopa. 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 Northera is droxidopa. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Northera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AB | 11 | AB |
| capsule, oral | 200MG | Marketed (Rx) | AB | 11 | AB |
| capsule, oral | 300MG | Marketed (Rx) | AB | 11 | AB |
NDA 203202, held by LUNDBECK NA LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic droxidopa
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALKEM LABORATORIES LTD | 213911 | AB (A-rated, therapeutically equivalent) | February 18, 2021 | 100MG, 200MG, 300MG |
| AUROBINDO PHARMA LTD | 214387 | AB (A-rated, therapeutically equivalent) | February 18, 2021 | 100MG, 200MG, 300MG |
| JUBILANT CADISTA PHARMACEUTICALS INC | 214391 | AB (A-rated, therapeutically equivalent) | February 18, 2021 | 100MG, 200MG, 300MG |
| MSN PHARMACEUTICALS INC | 211741 | AB (A-rated, therapeutically equivalent) | February 18, 2021 | 100MG, 200MG, 300MG |
| SCIEGEN PHARMACEUTICALS INC | 214017 | AB (A-rated, therapeutically equivalent) | February 18, 2021 | 100MG, 200MG, 300MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 214384 | AB (A-rated, therapeutically equivalent) | February 18, 2021 | 100MG, 200MG, 300MG |
| ZYDUS PHARMACEUTICALS USA INC | 211818 | AB (A-rated, therapeutically equivalent) | February 18, 2021 | 100MG, 200MG, 300MG |
| BIONPHARMA INC | 213033 | AB (A-rated, therapeutically equivalent) | April 28, 2021 | 100MG, 200MG, 300MG |
| SOMERSET THERAPEUTICS LLC | 214543 | AB (A-rated, therapeutically equivalent) | May 5, 2021 | 100MG, 200MG, 300MG |
| ANNORA PHARMA PRIVATE LTD | 211726 | AB (A-rated, therapeutically equivalent) | August 9, 2021 | 100MG, 200MG, 300MG |
| PHARMAZONE | 215265 | AB (A-rated, therapeutically equivalent) | November 1, 2021 | 100MG, 200MG, 300MG |
Northera NDC codes
Questions
Is there a generic for Northera?
Yes. The generic name for Northera is droxidopa. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Northera?
The active ingredient in Northera is droxidopa, 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.