NDC 0378-4500

Budesonide

Budesonide

Budesonide is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Budesonide.

Product ID0378-4500_0a2368b6-efdc-4d6d-b7bd-17cb44e0717b
NDC0378-4500
Product TypeHuman Prescription Drug
Proprietary NameBudesonide
Generic NameBudesonide
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-10-20
Marketing End Date2030-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA208851
Labeler NameMylan Pharmaceuticals Inc.
Substance NameBUDESONIDE
Active Ingredient Strength9 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0378-4500-93

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4500-93)
Marketing Start Date2020-10-20
Marketing End Date2030-01-31
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
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.