NDC product

Dapagliflozin and Metformin Hydrochloride

NDC 33342-407 · Macleods Pharmaceuticals Limited

Key facts

Product NDC 33342-407
Proprietary name Dapagliflozin and Metformin Hydrochloride
Nonproprietary name Dapagliflozin and Metformin Hydrochloride
Substances DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA211559
Pharmacologic classes Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
Marketing start Apr 6, 2026
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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