NDC 70934-291

PredniSONE

Prednisone

PredniSONE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. The primary component is Prednisone.

Product ID70934-291_8a85c50c-989d-4c73-e053-2995a90a0a72
NDC70934-291
Product TypeHuman Prescription Drug
Proprietary NamePredniSONE
Generic NamePrednisone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-02-21
Marketing CategoryANDA / ANDA
Application NumberANDA084122
Labeler NameDenton Pharma, Inc. DBA Northwind Pharmaceuticals
Substance NamePREDNISONE
Active Ingredient Strength10 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70934-291-12

12 TABLET in 1 BOTTLE, PLASTIC (70934-291-12)
Marketing Start Date2020-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70934-291-42 [70934029142]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084122
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-09

NDC 70934-291-12 [70934029112]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084122
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-09

NDC 70934-291-30 [70934029130]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084122
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-21

NDC 70934-291-15 [70934029115]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084122
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-09

NDC 70934-291-40 [70934029140]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084122
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-09

NDC 70934-291-20 [70934029120]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084122
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-21

NDC 70934-291-21 [70934029121]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084122
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-06

Drug Details

Active Ingredients

IngredientStrength
PREDNISONE10 mg/1

Pharmacological Class

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

NDC Crossover Matching brand name "PredniSONE" or generic name "Prednisone"

NDCBrand NameGeneric Name
0054-0017PredniSONEPredniSONE
0054-0018PredniSONEPredniSONE
0054-0019PredniSONEPredniSONE
0054-3722PredniSONEPredniSONE
0054-4728PredniSONEPredniSONE
0054-4741PredniSONEPredniSONE
68071-1777PrednisonePrednisone
68071-1779PrednisonePrednisone
68071-3143PrednisonePrednisone
68071-4319PrednisonePrednisone
68071-4546PrednisonePrednisone
68071-4685PrednisonePrednisone
68071-4691PrednisonePrednisone
68071-4491PrednisonePrednisone
68151-0820PredniSONEPredniSONE
0440-8167PrednisonePrednisone
0440-8165PrednisonePrednisone
0463-6155PredniSONEPredniSONE
68258-3013PrednisonePrednisone
0463-6141PredniSONEPredniSONE
68387-240PrednisonePrednisone
68387-241PrednisonePrednisone
68788-6440PrednisonePrednisone
68788-6414PrednisonePrednisone
68788-7281PrednisonePrednisone
68788-7372PrednisonePrednisone
68788-9309PrednisonePrednisone
68788-9178PrednisonePrednisone
68788-9551PrednisonePrednisone
0054-4742PredniSONEPredniSONE
0054-8739PredniSONEPredniSONE
0054-8724PredniSONEPredniSONE
0054-8740PredniSONEPredniSONE
70518-0305PrednisonePrednisone
70518-0307PrednisonePrednisone
70518-0205PrednisonePrednisone
70518-0306PredniSONEPredniSONE
70518-0242PrednisonePrednisone
70518-0073PrednisonePrednisone
70518-0473PrednisonePrednisone
70518-0632PrednisonePrednisone
70518-1116PredniSONEPredniSONE
70518-1167PrednisonePrednisone
70518-0948PrednisonePrednisone
70518-0800PrednisonePrednisone
70518-1105PredniSONEPredniSONE
70518-1119PrednisonePrednisone
70518-1120PrednisonePrednisone
0591-5442PrednisonePrednisone
70518-1854PrednisonePrednisone

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