NDC 47335-631

Budesonide

Budesonide

Budesonide is a Respiratory (inhalation) Suspension in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Budesonide.

Product ID47335-631_bd3a9267-8719-4d38-bcb3-6001792d06c7
NDC47335-631
Product TypeHuman Prescription Drug
Proprietary NameBudesonide
Generic NameBudesonide
Dosage FormSuspension
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2021-05-01
Marketing CategoryANDA /
Application NumberANDA211922
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameBUDESONIDE
Active Ingredient Strength0 mg/2mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 47335-631-49

6 POUCH in 1 CARTON (47335-631-49) > 5 AMPULE in 1 POUCH (47335-631-48) > 2 mL in 1 AMPULE
Marketing Start Date2021-05-01
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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