Orange Book product · Brand (NDA)
MACROBID
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
At a glance
Dec 24, 1991
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 24, 1991
35 yr ago
Today
Pharmaceutical detail
Active ingredient
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Strength
75MG;25MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 020064
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2026NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 220269 · CREEKWOOD PHARMS
- 2023NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 217073 · OMSAV PHARMA
- 2023NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 217357 · MANKIND PHARMA
- 2023NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 209225 · AUROBINDO PHARMA
- 2022NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 215002 · ALVOGEN
- 2022NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 211013 · INVENTIA
- 2018NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 208516 · SUNNY
- 2017NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 207372 · AMNEAL PHARMS
- 2015NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 202250 · WATSON LABS INC
- 2005NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 077066 · SANDOZ
- 2005NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 076951 · RANBAXY LABS LTD
- 2004NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Generic (ANDA)
ANDA 076648 · CHARTWELL RX
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
