NDC 71335-1069

nitrofurantoin

Nitrofurantoin Macrocrystals

nitrofurantoin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Nitrofurantoin.

Product ID71335-1069_aca04d52-8a64-4fca-94b2-64b46f5a3218
NDC71335-1069
Product TypeHuman Prescription Drug
Proprietary Namenitrofurantoin
Generic NameNitrofurantoin Macrocrystals
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-02-15
Marketing CategoryANDA / ANDA
Application NumberANDA205005
Labeler NameBryant Ranch Prepack
Substance NameNITROFURANTOIN
Active Ingredient Strength100 mg/1
Pharm ClassesNitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-1069-1

40 CAPSULE in 1 BOTTLE (71335-1069-1)
Marketing Start Date2021-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1069-5 [71335106905]

nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA205005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-28

NDC 71335-1069-1 [71335106901]

nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA205005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-28

NDC 71335-1069-9 [71335106909]

nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA205005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-28

NDC 71335-1069-8 [71335106908]

nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA205005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-28

NDC 71335-1069-2 [71335106902]

nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA205005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-28

NDC 71335-1069-4 [71335106904]

nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA205005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-28

NDC 71335-1069-6 [71335106906]

nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA205005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-28

NDC 71335-1069-3 [71335106903]

nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA205005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-28

NDC 71335-1069-7 [71335106907]

nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA205005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-28

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN100 mg/1

OpenFDA Data

SPL SET ID:aca04d52-8a64-4fca-94b2-64b46f5a3218
Manufacturer
UNII

Pharmacological Class

  • Nitrofurans [CS]
  • Nitrofuran Antibacterial [EPC]
  • Nitrofurans [CS]
  • Nitrofuran Antibacterial [EPC]

NDC Crossover Matching brand name "nitrofurantoin" or generic name "Nitrofurantoin Macrocrystals"

NDCBrand NameGeneric Name
0115-2023NitrofurantoinNitrofurantoin
0115-2024NitrofurantoinNitrofurantoin
0472-1992NitrofurantoinNitrofurantoin
0591-3684NitrofurantoinNitrofurantoin
0591-3685NitrofurantoinNitrofurantoin
0591-3686NitrofurantoinNitrofurantoin
0615-1308NitrofurantoinNitrofurantoin
0615-7655NitrofurantoinNitrofurantoin
13811-719NitrofurantoinNitrofurantoin
16571-740NitrofurantoinNitrofurantoin
40032-450NitrofurantoinNitrofurantoin
42291-574NitrofurantoinNitrofurantoin monohydrate/macrocrystals
70408-239NITROFURANTOINNITROFURANTOIN
71335-0878NitrofurantoinNitrofurantoin
76413-144NitrofurantoinNitrofurantoin
43386-450NitrofurantoinNitrofurantoin
50090-3737NitrofurantoinNitrofurantoin
51655-611NitrofurantoinNitrofurantoin
53002-7041NitrofurantoinNitrofurantoin
65162-689NitrofurantoinNitrofurantoin
71335-1069nitrofurantoinnitrofurantoin
71335-1135NitrofurantoinNitrofurantoin
63629-7968NitrofurantoinNitrofurantoin
60687-483NitrofurantoinNitrofurantoin
60687-472NitrofurantoinNitrofurantoin
68071-5050NitrofurantoinNitrofurantoin
68001-423NitrofurantoinNitrofurantoin
71205-365NitrofurantoinNitrofurantoin
71205-370NitrofurantoinNitrofurantoin
71335-1374NitrofurantoinNitrofurantoin
68071-2281NitrofurantoinNitrofurantoin
0115-1643Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
0440-1866Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
0904-7025nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
0904-7026nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
0904-7136nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
10544-601Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
40032-641Nitrofurantoin macrocrystalsNitrofurantoin macrocrystals
40032-642Nitrofurantoin macrocrystalsNitrofurantoin macrocrystals
42254-070Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
43063-400Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals

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