FDA Orange Book
Generic for Lanoxin
Lanoxin contains digoxin. 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 Lanoxin is digoxin. 6 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 7 Lanoxin products the Orange Book lists.
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Lanoxin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.25MG/ML | Marketed (Rx) | AP | 2 | AP |
| tablet, oral | 0.0625MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 0.125MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 0.1875MG | Discontinued | None | 0 | None |
| tablet, oral | 0.25MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 0.375MG | Discontinued | None | 0 | None |
| tablet, oral | 0.5MG | Discontinued | None | 0 | None |
NDA 009330, 020405, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic digoxin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDING INC | 040282 | AB (A-rated, therapeutically equivalent) | December 23, 1999 | 0.125MG, 0.25MG |
| JEROME STEVENS PHARMACEUTICALS INC | 076268 | AB (A-rated, therapeutically equivalent) | July 26, 2002 | 0.125MG, 0.25MG |
| SANDOZ INC | 040481 | AP (A-rated, therapeutically equivalent) | August 21, 2003 | 0.25MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 077002 | AB (A-rated, therapeutically equivalent) | October 30, 2007 | 0.125MG, 0.25MG |
| AUROBINDO PHARMA LTD | 214982 | AB (A-rated, therapeutically equivalent) | February 8, 2022 | 0.0625MG, 0.125MG, 0.25MG |
| NOVITIUM PHARMA LLC | 215307 | AB (A-rated, therapeutically equivalent) | August 25, 2022 | 0.0625MG, 0.125MG, 0.25MG |
| HIKMA PHARMACEUTICALS USA INC | 083391 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 0.25MG/ML |
Lanoxin NDC codes
Questions
Is there a generic for Lanoxin?
Yes. The generic name for Lanoxin is digoxin. 6 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 7 Lanoxin products the Orange Book lists.
What is the generic name for Lanoxin?
The active ingredient in Lanoxin is digoxin, 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.