Home NDC 67877-609 Dapagliflozin
Product NDC 67877-609
11-digit product format 678770609
Labeler code 67877
Product ID 67877-609_64617eef-d520-422b-aa99-d259b60c865f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapagliflozin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA211545
Marketing category ANDA
Marketing start 2026-04-06
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 44 .
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 A211545-001 DAPAGLIFLOZIN DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 A211545-002 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 A211545-001 PC 2026-10-03 A211545-002 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 2026-10-15 13:18:30 2026-09 A211545-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211545-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211545-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211545-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211545-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211545-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211545-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211545-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# 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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67877-609-05 Dapagliflozin 500 in 1 BOTTLE TABLET, FILM COATED 500 9 67877-609-30 Dapagliflozin 30 in 1 BOTTLE TABLET, FILM COATED 30 9 67877-609-33 Dapagliflozin 1 in 1 CARTON TABLET, FILM COATED 1 9 67877-609-33 Dapagliflozin 10 in 1 BLISTER PACK TABLET, FILM COATED 10 9 67877-609-90 Dapagliflozin 90 in 1 BOTTLE TABLET, FILM COATED 90 9
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67877-609-05 67877060905 500 TABLET, FILM COATED in 1 BOTTLE (67877-609-05) 2026-04-06 No No Current 67877-609-30 67877060930 30 TABLET, FILM COATED in 1 BOTTLE (67877-609-30) 2026-04-06 No No Current 67877-609-33 67877060933 1 BLISTER PACK in 1 CARTON (67877-609-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2026-04-06 No No Current 67877-609-90 67877060990 90 TABLET, FILM COATED in 1 BOTTLE (67877-609-90) 2026-04-06 No No Current