Active substances
Nitrofurantoin + Nitrofurantoin macrocrystalline
- US FDA 13
- UK MHRA 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MACROBID | 75MG;25MG | capsule · oral | ALMATICA | Prescription | 24 Dec 1991 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | SANDOZ | Prescription | 5 Apr 2005 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | WATSON LABS INC | Prescription | 8 Jul 2015 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | SUNNY | Prescription | 24 May 2018 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | INVENTIA | Prescription | 18 Feb 2022 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | AUROBINDO PHARMA | Prescription | 30 Mar 2023 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | MANKIND PHARMA | Prescription | 11 Jul 2023 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | MICRO LABS | Prescription | 3 Nov 2023 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | PHARMAZONE | Prescription | 7 Apr 2026 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | CHARTWELL RX | Discontinued | 22 Mar 2004 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | RANBAXY LABS LTD | Discontinued | 30 Mar 2005 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | AMNEAL PHARMS | Discontinued | 15 May 2017 |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | capsule · oral | ALVOGEN | Discontinued | 20 Jul 2022 |
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| NITROFURANTOIN GLENMARK 100 MG PROLONGED-RELEASE HARD CAPSULES | PL 25258/0448 | GLENMARK PHARMACEUTICALS EUROPE LIMITED | POM |
| NITROFURANTOIN SYNCHRONY PHARMA 100 MG PROLONGED-RELEASE CAPSULES | PL 39280/0035 | SYNCHRONY PHARMA LIMITED | POM |
Components
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.