NDC 68382-720

budesonide

Budesonide

budesonide is a Oral Capsule, Coated Pellets in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Budesonide.

Product ID68382-720_124a7bcf-1e7b-4447-860e-697b9ae50a87
NDC68382-720
Product TypeHuman Prescription Drug
Proprietary Namebudesonide
Generic NameBudesonide
Dosage FormCapsule, Coated Pellets
Route of AdministrationORAL
Marketing Start Date2017-06-08
Marketing CategoryANDA / ANDA
Application NumberANDA206134
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameBUDESONIDE
Active Ingredient Strength3 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68382-720-01

100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-01)
Marketing Start Date2017-06-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-720-30 [68382072030]

budesonide CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA206134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-08

NDC 68382-720-10 [68382072010]

budesonide CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA206134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-08

NDC 68382-720-05 [68382072005]

budesonide CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA206134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-08

NDC 68382-720-01 [68382072001]

budesonide CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA206134
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-08

NDC 68382-720-77 [68382072077]

budesonide CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA206134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-08

NDC 68382-720-06 [68382072006]

budesonide CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA206134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-08

NDC 68382-720-16 [68382072016]

budesonide CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA206134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-08

Drug Details

Pharmacological Class

  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]

Medicade Reported Pricing

68382072001 BUDESONIDE EC 3 MG CAPSULE

Pricing Unit: EA | Drug Type:

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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.