"67877-622-38" National Drug Code (NDC)

Dapagliflozin And Metformin Hydrochloride 10 BLISTER PACK in 1 CARTON (67877-622-38) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
(Ascend Laboratories, LLC)

NDC Code67877-622-38
Package Description10 BLISTER PACK in 1 CARTON (67877-622-38) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product NDC67877-622
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDapagliflozin And Metformin Hydrochloride
Non-Proprietary NameDapagliflozin And Metformin Hydrochloride
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20260406
Marketing Category NameANDA
Application NumberANDA211563
ManufacturerAscend Laboratories, LLC
Substance NameDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Strength10; 1000
Strength Unitmg/1; mg/1
Pharmacy ClassesBiguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]

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