NDC directory

Dapagliflozin

Micro Labs Limited · TABLET

42571-318ANDASodium-Glucose Cotransporter 2 Inhibitor [EPC]
Product NDC
42571-318
Generic name
Dapagliflozin
Labeler name
Micro Labs Limited
Brand name
Dapagliflozin
Finished
true
Listing expiration date
20271231
Marketing category
ANDA
Dosage form
TABLET
SPL ID
4eee1c9a-00d2-3d23-e063-6294a90a72cd
Product type
HUMAN PRESCRIPTION DRUG
Marketing start date
20261001
Product ID
42571-318_4eee1c9a-00d2-3d23-e063-6294a90a72cd
Application number
ANDA211467
Brand name base
Dapagliflozin
Active ingredients
  1. Name
    DAPAGLIFLOZIN
    Strength
    10 mg/1
Packaging
  1. Package NDC
    42571-318-10
    Description
    1000 TABLET in 1 BOTTLE (42571-318-10)
    Marketing start date
    20261001
    Sample
    false
  2. Package NDC
    42571-318-30
    Description
    30 TABLET in 1 BOTTLE (42571-318-30)
    Marketing start date
    20261001
    Sample
    false
  3. Package NDC
    42571-318-90
    Description
    90 TABLET in 1 BOTTLE (42571-318-90)
    Marketing start date
    20261001
    Sample
    false
Route
ORAL
Pharm class
Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.