Home NDC 27241-151 Dapagliflozin
Product NDC 27241-151
11-digit product format 272410151
Labeler code 27241
Product ID 27241-151_af7c3e48-a7c2-4f5a-b812-b0c089fa2a79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapagliflozin
Dosage form TABLET
Route ORAL
Labeler Ajanta Pharma USA Inc.
Application ANDA211482
Marketing category ANDA
Marketing start 2026-04-06
Substance DAPAGLIFLOZIN
Active strength 5 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 A211482-001 DAPAGLIFLOZIN DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 A211482-002 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 A211482-001 PC 2026-10-03 A211482-002 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 A211482-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211482-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211482-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211482-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211482-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211482-002 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 A211482-001 PC 2026-10-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211482-002 PC 2026-10-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211482-001 PC 2026-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211482-002 PC 2026-10-03 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211482-001 PC 2026-10-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211482-002 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 5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 27241-151-01 Dapagliflozin 30 in 1 BOTTLE TABLET 30 10
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 27241-151-01 27241015101 30 TABLET in 1 BOTTLE (27241-151-01) 30 tablet 2026-04-06 No No Current 27241-151-90 27241015190 90 TABLET in 1 BOTTLE (27241-151-90) 90 tablet 2026-09-02 No No Current