FDA Orange Book
Generic for Macrodantin
Macrodantin contains nitrofurantoin macrocrystalline. 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 Macrodantin is nitrofurantoin macrocrystalline. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Macrodantin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Discontinued | None | 7 | AB |
| capsule, oral | 25MG | Discontinued | None | 3 | AB |
| capsule, oral | 50MG | Discontinued | None | 6 | AB |
NDA 016620, held by ALMATICA 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 macrocrystalline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 073652 | AB (A-rated, therapeutically equivalent) | January 28, 1993 | 100MG |
| IMPAX LABORATORIES INC | 073671 | AB (A-rated, therapeutically equivalent) | January 28, 1993 | 50MG |
| AUROBINDO PHARMA USA INC | 074967 | AB (A-rated, therapeutically equivalent) | July 9, 1997 | 100MG, 50MG |
| AUROBINDO PHARMA USA INC | 077025 | AB (A-rated, therapeutically equivalent) | August 18, 2004 | 100MG, 25MG |
| ZYDUS PHARMACEUTICALS USA INC | 205005 | AB (A-rated, therapeutically equivalent) | December 12, 2017 | 100MG, 50MG |
| NOVEL LABORATORIES INC | 203233 | AB (A-rated, therapeutically equivalent) | July 9, 2018 | 100MG, 50MG |
| ALEMBIC PHARMACEUTICALS LTD | 211935 | AB (A-rated, therapeutically equivalent) | June 25, 2021 | 100MG, 25MG, 50MG |
| MANKIND PHARMA LTD | 217272 | AB (A-rated, therapeutically equivalent) | March 21, 2023 | 100MG, 25MG, 50MG |
Macrodantin NDC codes
Questions
Is there a generic for Macrodantin?
Yes. The generic name for Macrodantin is nitrofurantoin macrocrystalline. 6 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 Macrodantin?
The active ingredient in Macrodantin is nitrofurantoin macrocrystalline, 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.