Last Updated: November 9, 2026

Details for New Drug Application (NDA): 016620

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NDA 016620 describes MACRODANTIN, which is a drug marketed by Almatica and is included in one NDA. It is available from one supplier. Additional details are available on the MACRODANTIN profile page.

The generic ingredient in MACRODANTIN is nitrofurantoin, macrocrystalline. There is one drug master file entry for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the nitrofurantoin, macrocrystalline profile page.
Summary for 016620
Tradename:MACRODANTIN
Applicant:Almatica
Ingredient:nitrofurantoin, macrocrystalline
Patents:0
Pharmacology for NDA: 016620
Suppliers and Packaging for NDA: 016620
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MACRODANTIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 016620 NDA Proficient Rx LP 63187-245 63187-245-10 10 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-10)
MACRODANTIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 016620 NDA Proficient Rx LP 63187-245 63187-245-14 14 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-14)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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