NDC 0615-1308

Nitrofurantoin

Nitrofurantoin

Nitrofurantoin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Nitrofurantoin.

Product ID0615-1308_f2863415-3b07-410b-9413-0627bf8b5c84
NDC0615-1308
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin
Generic NameNitrofurantoin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1997-07-09
Marketing CategoryANDA / ANDA
Application NumberANDA074967
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameNITROFURANTOIN
Active Ingredient Strength50 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0615-1308-39

30 CAPSULE in 1 BLISTER PACK (0615-1308-39)
Marketing Start Date2010-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-1308-39 [00615130839]

Nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA074967
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-15
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN50 mg/1

OpenFDA Data

SPL SET ID:92c6c41b-21b8-44e6-89eb-8e8c9170f4db
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648759
  • 311995

    • Pharmacological Class

    • Nitrofurans [CS]
    • Nitrofuran Antibacterial [EPC]

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

    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
    43386-450NitrofurantoinNitrofurantoin
    46708-389NITROFURANTOINNITROFURANTOIN
    46708-390NITROFURANTOINNITROFURANTOIN
    46708-391NITROFURANTOINNITROFURANTOIN
    50090-3737NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    50090-3856NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    50090-4570NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50090-4591NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50268-625NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    51655-611NitrofurantoinNitrofurantoin
    53002-7041NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    53002-7042NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    55700-794NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    60687-472NitrofurantoinNitrofurantoin
    60687-483NitrofurantoinNitrofurantoin
    60687-633NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    60760-478NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    70408-239NITROFURANTOINNITROFURANTOIN
    71335-0878NitrofurantoinNitrofurantoin
    76413-144NitrofurantoinNitrofurantoin
    65162-689NitrofurantoinNitrofurantoin
    71335-1069nitrofurantoinnitrofurantoin
    71335-1135NitrofurantoinNitrofurantoin
    63629-7968NitrofurantoinNitrofurantoin
    68071-5050NitrofurantoinNitrofurantoin
    68001-423NitrofurantoinNitrofurantoin
    71205-365NitrofurantoinNitrofurantoin
    71205-370NitrofurantoinNitrofurantoin
    71335-1374NitrofurantoinNitrofurantoin
    68071-2281NitrofurantoinNitrofurantoin
    59630-450Furadantinnitrofurantoin
    61919-458NITROFURANTOIN MACROCRYSTALSnitrofurantoin
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