Home NDC 42571-318 Dapagliflozin
Product NDC 42571-318
11-digit product format 425710318
Labeler code 42571
Product ID 42571-318_4eee1c9a-00d2-3d23-e063-6294a90a72cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapagliflozin
Dosage form TABLET
Route ORAL
Labeler Micro Labs Limited
Application ANDA211467
Marketing category ANDA
Marketing start 2026-10-01
Substance DAPAGLIFLOZIN
Active strength 10 mg/1
Pharmacologic classes Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211467-001 DAPAGLIFLOZIN DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 A211467-002 DAPAGLIFLOZIN DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A211467-001 PC 2026-10-03 A211467-002 PC 2026-10-03
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A211467-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211467-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211467-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211467-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211467-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211467-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 A211467-001 PC 2026-10-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211467-002 PC 2026-10-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211467-001 PC 2026-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211467-002 PC 2026-10-03 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211467-001 PC 2026-10-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211467-002 PC 2026-10-03 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dapagliflozin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAPAGLIFLOZIN 10 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42571-318-10 42571031810 1000 TABLET in 1 BOTTLE (42571-318-10) 1000 tablet 2026-10-01 No No Current 42571-318-30 42571031830 30 TABLET in 1 BOTTLE (42571-318-30) 30 tablet 2026-10-01 No No Current 42571-318-90 42571031890 90 TABLET in 1 BOTTLE (42571-318-90) 90 tablet 2026-10-01 No No Current