NDC 70748-105

Dapagliflozin

Dapagliflozin

Dapagliflozin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Dapagliflozin.

Product ID70748-105_b2ba541f-f831-499b-9161-c54ae831900c
NDC70748-105
Product TypeHuman Prescription Drug
Proprietary NameDapagliflozin
Generic NameDapagliflozin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA211531
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameDAPAGLIFLOZIN
Active Ingredient Strength5 mg/1
Pharm ClassesSodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70748-105-01

100 TABLET in 1 BOTTLE (70748-105-01)
Marketing Start Date2018-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70748-105-09 [70748010509]

Dapagliflozin TABLET
Marketing CategoryANDA
Application NumberANDA211531
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-15
Inactivation Date2020-01-31

NDC 70748-105-01 [70748010501]

Dapagliflozin TABLET
Marketing CategoryANDA
Application NumberANDA211531
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-15
Inactivation Date2020-01-31

NDC 70748-105-02 [70748010502]

Dapagliflozin TABLET
Marketing CategoryANDA
Application NumberANDA211531
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-15
Inactivation Date2020-01-31

NDC 70748-105-06 [70748010506]

Dapagliflozin TABLET
Marketing CategoryANDA
Application NumberANDA211531
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DAPAGLIFLOZIN5 mg/1

Pharmacological Class

  • Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
  • Sodium-Glucose Transporter 2 Inhibitors [MoA]

NDC Crossover Matching brand name "Dapagliflozin" or generic name "Dapagliflozin"

NDCBrand NameGeneric Name
70748-106DapagliflozinDapagliflozin
70748-105DapagliflozinDapagliflozin
0310-6205FARXIGADAPAGLIFLOZIN
0310-6210FARXIGADAPAGLIFLOZIN
50090-3481FARXIGADAPAGLIFLOZIN
50090-3482FARXIGADAPAGLIFLOZIN
55154-6932FARXIGADAPAGLIFLOZIN
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