FDA Orange Book
Generic for Macrobid
Macrobid contains nitrofurantoin and 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 Macrobid is nitrofurantoin and nitrofurantoin macrocrystalline. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Macrobid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 75MG;25MG | Marketed (Rx) | AB | 8 | AB |
NDA 020064, 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 and nitrofurantoin macrocrystalline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 077066 | AB (A-rated, therapeutically equivalent) | April 5, 2005 | 75MG;25MG |
| WATSON LABORATORIES INC | 202250 | AB (A-rated, therapeutically equivalent) | July 8, 2015 | 75MG;25MG |
| SUNNY PHARMTECH INC | 208516 | AB (A-rated, therapeutically equivalent) | May 24, 2018 | 75MG;25MG |
| INVENTIA HEALTHCARE LTD | 211013 | AB (A-rated, therapeutically equivalent) | February 18, 2022 | 75MG;25MG |
| AUROBINDO PHARMA LTD | 209225 | AB (A-rated, therapeutically equivalent) | March 30, 2023 | 75MG;25MG |
| MANKIND PHARMA LTD | 217357 | AB (A-rated, therapeutically equivalent) | July 11, 2023 | 75MG;25MG |
| MICRO LABS LTD | 217073 | AB (A-rated, therapeutically equivalent) | November 3, 2023 | 75MG;25MG |
| PHARMAZONE | 220269 | AB (A-rated, therapeutically equivalent) | April 7, 2026 | 75MG;25MG |
Macrobid NDC codes
Questions
Is there a generic for Macrobid?
Yes. The generic name for Macrobid is nitrofurantoin and nitrofurantoin macrocrystalline. 8 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 Macrobid?
The active ingredient in Macrobid is nitrofurantoin and 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.