NDC 0536-1112

Budesonide

Budesonide

Budesonide is a Nasal Spray, Metered in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Budesonide.

Product ID0536-1112_0286a401-5ef5-8fc3-c176-7f41570f941b
NDC0536-1112
Product TypeHuman Otc Drug
Proprietary NameBudesonide
Generic NameBudesonide
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2016-07-13
Marketing CategoryANDA / ANDA
Application NumberANDA078949
Labeler NameRugby Laboratories
Substance NameBUDESONIDE
Active Ingredient Strength32 ug/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0536-1112-40

1 BOTTLE, SPRAY in 1 CARTON (0536-1112-40) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY
Marketing Start Date2016-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-1112-40 [00536111240]

Budesonide SPRAY, METERED
Marketing CategoryANDA
Application NumberANDA078949
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-20

NDC 0536-1112-48 [00536111248]

Budesonide SPRAY, METERED
Marketing CategoryANDA
Application NumberANDA078949
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-07-20

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE32 ug/1

OpenFDA Data

SPL SET ID:04eb9e98-1323-353f-3fd7-2d317dfac526
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797929
  • NDC Crossover Matching brand name "Budesonide" or generic name "Budesonide"

    NDCBrand NameGeneric Name
    0093-6815BudesonideBudesonide
    0093-6816BudesonideBudesonide
    0093-6817BudesonideBudesonide
    0093-7445BudesonideBudesonide
    68151-4374BudesonideBudesonide
    68258-8922BudesonideBudesonide
    68382-720budesonidebudesonide
    0487-9601BudesonideBudesonide
    0487-9701BudesonideBudesonide
    68788-0012BudesonideBudesonide
    68682-309budesonidebudesonide
    68788-6873BudesonideBudesonide
    68788-0013BudesonideBudesonide
    68788-6796BudesonideBudesonide
    68788-7020BudesonideBudesonide
    0536-1112BudesonideBudesonide
    69842-001BudesonideBudesonide
    0574-9855budesonidebudesonide
    0591-2510BudesonideBudesonide
    70771-1075budesonidebudesonide
    0781-7517BudesonideBudesonide
    0781-7515BudesonideBudesonide
    0781-7516BudesonideBudesonide
    11822-6000BudesonideBudesonide
    16714-829budesonidebudesonide
    21130-710BudesonideBudesonide
    36800-113BudesonideBudesonide
    46122-389BudesonideBudesonide
    49035-703BudesonideBudesonide
    51079-020BudesonideBudesonide
    0363-0048BudesonideBudesonide
    60505-6194BudesonideBudesonide
    60429-264BudesonideBudesonide
    60505-0820BUDESONIDEBUDESONIDE
    60505-0821BUDESONIDEBUDESONIDE
    60505-6129BudesonideBudesonide
    60687-421BudesonideBudesonide
    64980-255BudesonideBudesonide
    0378-7155BudesonideBudesonide
    65162-778BudesonideBudesonide
    0115-1687Budesonide InhalationBudesonide
    0115-1689Budesonide InhalationBudesonide
    0186-0916PULMICORTBudesonide
    0186-0917PULMICORTBudesonide
    0186-1988PULMICORT RESPULESBudesonide
    0186-1989PULMICORT RESPULESBudesonide
    0186-1990PULMICORT RESPULESBudesonide

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