Home NDC 0310-6780-95 QTERN
Product NDC 0310-6780
Requested package NDC 0310-6780-95
11-digit product format 003106780
Labeler code 0310
Product ID 0310-6780_702d38dd-1db2-4452-824c-1410452ec672
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dapagliflozin and saxagliptin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA209091
Marketing category NDA
Marketing start 2017-12-04
Marketing end 0000-00-00
Substance DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Active strength 10 mg/1; mg/1
Pharmacologic classes Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N209091-001 QTERN DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2017-02-27 N209091-002 QTERN DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE 5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-02
Orange Book patents# Current patent rows page 1 of 1 · 28 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209091-001 6515117 2025-10-04 U-493 Drug substance, Drug product 2017-03-22 N209091-001 6515117*PED 2026-04-04 Pediatric extension N209091-001 8501698 2027-06-20 U-1976 Drug product 2017-03-22 N209091-001 8501698 2027-06-20 U-1977 Drug product 2017-03-22 N209091-001 8501698 2027-06-20 U-493 Drug product 2017-03-22 N209091-001 8501698*PED 2027-12-20 Pediatric extension N209091-001 8221786 2028-03-21 Drug product 2017-03-22 N209091-001 8361972 2028-03-21 U-1976 2017-03-22 N209091-001 8361972 2028-03-21 U-1977 2017-03-22 N209091-001 8361972 2028-03-21 U-493 2017-03-22 N209091-001 8716251 2028-03-21 Drug product 2017-03-22 N209091-001 8221786*PED 2028-09-21 Pediatric extension N209091-001 8361972*PED 2028-09-21 Pediatric extension N209091-001 8716251*PED 2028-09-21 Pediatric extension N209091-001 7919598 2029-12-16 Drug substance 2017-03-22 N209091-001 7919598*PED 2030-06-16 Pediatric extension N209091-002 6515117 2025-10-04 U-493 Drug substance, Drug product 2019-05-24 N209091-002 6515117*PED 2026-04-04 Pediatric extension N209091-002 8501698 2027-06-20 U-493 Drug product 2019-05-24 N209091-002 8501698*PED 2027-12-20 Pediatric extension N209091-002 8221786 2028-03-21 Drug product 2019-05-24 N209091-002 8361972 2028-03-21 U-493 2019-05-24 N209091-002 8716251 2028-03-21 Drug product 2019-05-24 N209091-002 8221786*PED 2028-09-21 Pediatric extension N209091-002 8361972*PED 2028-09-21 Pediatric extension N209091-002 8716251*PED 2028-09-21 Pediatric extension N209091-002 7919598 2029-12-16 Drug substance 2019-05-24 N209091-002 7919598*PED 2030-06-16 Pediatric extension
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 2026-08-01 22:54:32 2026-06 N209091-001 QTERN 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2017-02-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 QTERN 5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-02 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N209091-001 6515117 2025-10-04 U-493 Drug substance, Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 6515117*PED 2026-04-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8501698 2027-06-20 U-1976 Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8501698 2027-06-20 U-1977 Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8501698 2027-06-20 U-493 Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8501698*PED 2027-12-20 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8221786 2028-03-21 Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8361972 2028-03-21 U-1977 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8361972 2028-03-21 U-1976 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8361972 2028-03-21 U-493 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8716251 2028-03-21 Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8221786*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8361972*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8716251*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 7919598 2029-12-16 Drug substance 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 7919598*PED 2030-06-16 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 6515117 2025-10-04 U-493 Drug substance, Drug product 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 6515117*PED 2026-04-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8501698 2027-06-20 U-493 Drug product 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8501698*PED 2027-12-20 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8221786 2028-03-21 Drug product 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8361972 2028-03-21 U-493 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8716251 2028-03-21 Drug product 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8221786*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8361972*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8716251*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 7919598 2029-12-16 Drug substance 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 7919598*PED 2030-06-16 Pediatric extension a50c72e98297…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-6780 QTERN (DAPAGLIFLOZIN AND SAXAGLIPTIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 31 Legacy NDC 20241116_423c489c-085b-4320-b892-7868ebd6dc6b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0310-6780-95 00310678095 7 TABLET, FILM COATED in 1 BLISTER PACK (0310-6780-95) 2017-12-04 2021-07-31 No No Current