Details for New Drug Application (NDA): 016620
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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 |
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 | Northwind Health Company, LLC | 51655-948 | 51655-948-20 | 20 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-20) |
| MACRODANTIN | nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 016620 | NDA | Northwind Health Company, LLC | 51655-948 | 51655-948-29 | 28 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-29) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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