FDA Orange Book
Generic for Furadantin
Furadantin contains nitrofurantoin. 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 Furadantin is nitrofurantoin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 4 Furadantin products the Orange Book lists.
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Furadantin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 25MG/5ML | Marketed (Rx) | AB | 8 | AB |
| suspension, oral | 50MG/5ML | Marketed (Rx) | None | 0 | None |
| tablet, oral | 100MG | Discontinued | None | 0 | None |
| tablet, oral | 50MG | Discontinued | None | 0 | None |
NDA 009175, 008693, held by CASPER PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nitrofurantoin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| STRIDES PHARMA GLOBAL PTE LTD | 201355 | AB (A-rated, therapeutically equivalent) | August 14, 2013 | 25MG/5ML |
| NOVEL LABORATORIES INC | 201693 | AB (A-rated, therapeutically equivalent) | September 8, 2014 | 25MG/5ML |
| ACTAVIS MID ATLANTIC LLC | 205180 | AB (A-rated, therapeutically equivalent) | May 3, 2016 | 25MG/5ML |
| NOVITIUM PHARMA LLC | 216385 | AB (A-rated, therapeutically equivalent) | April 14, 2023 | 25MG/5ML |
| AUROBINDO PHARMA LTD | 212607 | AB (A-rated, therapeutically equivalent) | May 11, 2023 | 25MG/5ML |
| BIOCON PHARMA INC | 218346 | AB (A-rated, therapeutically equivalent) | October 28, 2024 | 25MG/5ML |
| SOMERSET THERAPEUTICS LLC | 208909 | AB (A-rated, therapeutically equivalent) | January 14, 2025 | 25MG/5ML |
| ANNORA PHARMA PRIVATE LTD | 219495 | AB (A-rated, therapeutically equivalent) | July 2, 2025 | 25MG/5ML |
Furadantin NDC codes
Questions
Is there a generic for Furadantin?
Yes. The generic name for Furadantin is nitrofurantoin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 4 Furadantin products the Orange Book lists.
What is the generic name for Furadantin?
The active ingredient in Furadantin is nitrofurantoin, 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.