NDC 55289-186

Nitrofurantoin (macrocrystals)

Nitrofurantoin (macrocrystals)

Nitrofurantoin (macrocrystals) is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Nitrofurantoin.

Product ID55289-186_7bc060d2-bd77-4246-e053-2991aa0ae29d
NDC55289-186
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin (macrocrystals)
Generic NameNitrofurantoin (macrocrystals)
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1997-09-09
Marketing CategoryANDA /
Application NumberANDA074967
Labeler NamePD-Rx Pharmaceuticals, In
Substance NameNITROFURANTOIN
Active Ingredient Strength50 mg/1
Pharm ClassesNitrofurans [CS
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC SPL Data Element Entries

NDC 55289-186-14 [55289018614]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA074967
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-11-28
Marketing End Date2019-03-29

NDC 55289-186-28 [55289018628]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA074967
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-11-28
Marketing End Date2019-03-29

NDC 55289-186-20 [55289018620]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA074967
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-11-28
Marketing End Date2019-03-29

NDC 55289-186-12 [55289018612]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA074967
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-11-28
Marketing End Date2019-03-29

NDC 55289-186-21 [55289018621]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA074967
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-11-28
Marketing End Date2019-03-29

NDC 55289-186-40 [55289018640]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA074967
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-11-28
Marketing End Date2019-03-29

Drug Details

NDC Crossover Matching brand name "Nitrofurantoin (macrocrystals)" or generic name "Nitrofurantoin (macrocrystals)"

NDCBrand NameGeneric Name
0378-1650Nitrofurantoin (macrocrystals)nitrofurantoin (macrocrystals)
0378-1700Nitrofurantoin (macrocrystals)nitrofurantoin (macrocrystals)
35356-681Nitrofurantoin (macrocrystals)nitrofurantoin (macrocrystals)
55289-186Nitrofurantoin (macrocrystals)nitrofurantoin (macrocrystals)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.