Home NDC 0310-6250-95 XIGDUO
Product NDC 0310-6250
Requested package NDC 0310-6250-95
11-digit product format 003106250
Labeler code 0310
Product ID 0310-6250_a8717b28-9445-4292-9ac7-e979f378d9c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dapagliflozin and metformin hydrochloride
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA205649
Marketing category NDA
Marketing start 2014-10-29
Substance DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE
Active strength 5; 500 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205649-001 XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2014-10-29 N205649-002 XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB RLD 2014-10-29 N205649-003 XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2014-10-29 N205649-004 XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2014-10-29 N205649-005 XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB RLD 2017-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 50 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205649-001 6515117 2025-10-04 U-493 Drug substance, Drug product 2014-11-24 N205649-001 6515117*PED 2026-04-04 Pediatric extension N205649-001 8501698 2027-06-20 U-493 Drug product 2014-11-24 N205649-001 8501698*PED 2027-12-20 Pediatric extension N205649-001 7919598 2029-12-16 Drug substance 2014-11-24 N205649-001 8685934 2030-05-26 U-1522 2014-11-24 N205649-001 7919598*PED 2030-06-16 Pediatric extension N205649-001 9616028 2030-11-12 Drug product 2017-08-30 N205649-001 8685934*PED 2030-11-26 Pediatric extension N205649-001 9616028*PED 2031-05-12 Pediatric extension N205649-002 6515117 2025-10-04 U-493 Drug substance, Drug product 2014-11-24 N205649-002 6515117*PED 2026-04-04 Pediatric extension N205649-002 8501698 2027-06-20 U-493 Drug product 2014-11-24 N205649-002 8501698*PED 2027-12-20 Pediatric extension N205649-002 7919598 2029-12-16 Drug substance 2014-11-24 N205649-002 8685934 2030-05-26 U-1522 2014-11-24 N205649-002 7919598*PED 2030-06-16 Pediatric extension N205649-002 9616028 2030-11-12 Drug product 2017-08-30 N205649-002 8685934*PED 2030-11-26 Pediatric extension N205649-002 9616028*PED 2031-05-12 Pediatric extension N205649-003 6515117 2025-10-04 U-493 Drug substance, Drug product 2014-11-24 N205649-003 6515117*PED 2026-04-04 Pediatric extension N205649-003 8501698 2027-06-20 U-493 Drug product 2014-11-24 N205649-003 8501698*PED 2027-12-20 Pediatric extension N205649-003 7919598 2029-12-16 Drug substance 2014-11-24 N205649-003 8685934 2030-05-26 U-1522 2014-11-24 N205649-003 7919598*PED 2030-06-16 Pediatric extension N205649-003 9616028 2030-11-12 Drug product 2017-08-30 N205649-003 8685934*PED 2030-11-26 Pediatric extension N205649-003 9616028*PED 2031-05-12 Pediatric extension N205649-004 6515117 2025-10-04 U-493 Drug substance, Drug product 2014-11-24 N205649-004 6515117*PED 2026-04-04 Pediatric extension N205649-004 8501698 2027-06-20 U-493 Drug product 2014-11-24 N205649-004 8501698*PED 2027-12-20 Pediatric extension N205649-004 7919598 2029-12-16 Drug substance 2014-11-24 N205649-004 8685934 2030-05-26 U-1522 2014-11-24 N205649-004 7919598*PED 2030-06-16 Pediatric extension N205649-004 9616028 2030-11-12 Drug product 2017-08-30 N205649-004 8685934*PED 2030-11-26 Pediatric extension N205649-004 9616028*PED 2031-05-12 Pediatric extension N205649-005 6515117 2025-10-04 U-493 Drug substance, Drug product 2014-11-24 N205649-005 6515117*PED 2026-04-04 Pediatric extension N205649-005 8501698 2027-06-20 U-493 Drug product 2017-08-30 N205649-005 8501698*PED 2027-12-20 Pediatric extension N205649-005 7919598 2029-12-16 Drug substance 2017-08-30 N205649-005 8685934 2030-05-26 U-1522 2017-08-30 N205649-005 7919598*PED 2030-06-16 Pediatric extension N205649-005 9616028 2030-11-12 Drug product 2017-08-30 N205649-005 8685934*PED 2030-11-26 Pediatric extension N205649-005 9616028*PED 2031-05-12 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 10 matching rows.
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.
Product history page 1 of 4 · 145 observed 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 2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-001 XIGDUO XR 5MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-002 XIGDUO XR 5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-003 XIGDUO XR 10MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-004 XIGDUO XR 10MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2014-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-005 XIGDUO XR 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2017-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205649-001 XIGDUO XR 5MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205649-002 XIGDUO XR 5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205649-003 XIGDUO XR 10MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205649-004 XIGDUO XR 10MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2014-10-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205649-005 XIGDUO XR 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2017-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205649-001 XIGDUO XR 5MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205649-002 XIGDUO XR 5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205649-003 XIGDUO XR 10MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205649-004 XIGDUO XR 10MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2014-10-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205649-005 XIGDUO XR 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2017-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205649-001 XIGDUO XR 5MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205649-002 XIGDUO XR 5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205649-003 XIGDUO XR 10MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205649-004 XIGDUO XR 10MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2014-10-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205649-005 XIGDUO XR 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2017-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205649-001 XIGDUO XR 5MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205649-002 XIGDUO XR 5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205649-003 XIGDUO XR 10MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205649-004 XIGDUO XR 10MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2014-10-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205649-005 XIGDUO XR 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2017-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205649-001 XIGDUO XR 5MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205649-002 XIGDUO XR 5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205649-003 XIGDUO XR 10MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205649-004 XIGDUO XR 10MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2014-10-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205649-005 XIGDUO XR 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2017-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205649-001 XIGDUO XR 5MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205649-002 XIGDUO XR 5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205649-003 XIGDUO XR 10MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205649-004 XIGDUO XR 10MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2014-10-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205649-005 XIGDUO XR 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2017-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205649-001 XIGDUO XR 5MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205649-002 XIGDUO XR 5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205649-003 XIGDUO XR 10MG;500MG TABLET, EXTENDED RELEASE / ORAL RLD 2014-10-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205649-004 XIGDUO XR 10MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2014-10-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205649-005 XIGDUO XR 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2017-07-28 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 22 · 865 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-001 6515117 2025-10-04 U-493 Drug substance, Drug product 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-001 6515117*PED 2026-04-04 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-001 8501698 2027-06-20 U-493 Drug product 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-001 8501698*PED 2027-12-20 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-001 7919598 2029-12-16 Drug substance 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-001 8685934 2030-05-26 U-1522 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-001 7919598*PED 2030-06-16 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-001 9616028 2030-11-12 Drug product 2017-08-30 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-001 8685934*PED 2030-11-26 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-001 9616028*PED 2031-05-12 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-002 6515117 2025-10-04 U-493 Drug substance, Drug product 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-002 6515117*PED 2026-04-04 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-002 8501698 2027-06-20 U-493 Drug product 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-002 8501698*PED 2027-12-20 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-002 7919598 2029-12-16 Drug substance 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-002 8685934 2030-05-26 U-1522 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-002 7919598*PED 2030-06-16 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-002 9616028 2030-11-12 Drug product 2017-08-30 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-002 8685934*PED 2030-11-26 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-002 9616028*PED 2031-05-12 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-003 6515117 2025-10-04 U-493 Drug substance, Drug product 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-003 6515117*PED 2026-04-04 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-003 8501698 2027-06-20 U-493 Drug product 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-003 8501698*PED 2027-12-20 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-003 7919598 2029-12-16 Drug substance 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-003 8685934 2030-05-26 U-1522 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-003 7919598*PED 2030-06-16 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-003 9616028 2030-11-12 Drug product 2017-08-30 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-003 8685934*PED 2030-11-26 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-003 9616028*PED 2031-05-12 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-004 6515117 2025-10-04 U-493 Drug substance, Drug product 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-004 6515117*PED 2026-04-04 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-004 8501698 2027-06-20 U-493 Drug product 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-004 8501698*PED 2027-12-20 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-004 7919598 2029-12-16 Drug substance 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-004 8685934 2030-05-26 U-1522 2014-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-004 7919598*PED 2030-06-16 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-004 9616028 2030-11-12 Drug product 2017-08-30 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-004 8685934*PED 2030-11-26 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 N205649-004 9616028*PED 2031-05-12 Pediatric extension 1e350fbaab3a…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 125 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base XIGDUO
Brand name suffix XR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAPAGLIFLOZIN PROPANEDIOL 5 mg/1 METFORMIN HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 887K2391VH Internal UNII lookup 786Z46389E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1593058 Internal RxNorm lookup 1593068 Internal RxNorm lookup 1593070 Internal RxNorm lookup 1593072 Internal RxNorm lookup 1593775 Internal RxNorm lookup 1593831 Internal RxNorm lookup 1593833 Internal RxNorm lookup 1593835 Internal RxNorm lookup 1940496 Internal RxNorm lookup 1940498 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0310-6250-30 XIGDUOXR 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED, EXTENDED RE 30 38 0310-6250-95 XIGDUOXR 1 in 1 CARTON TABLET, FILM COATED, EXTENDED RE 1 38 0310-6250-95 XIGDUOXR 7 in 1 BLISTER PACK TABLET, FILM COATED, EXTENDED RE 7 38
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DAPAGLIFLOZIN PROPANEDIOL ACTIVE INGREDIENT 887K2391VH XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1 METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1 dapagliflozin ACTIVE MOIETY 1ULL0QJ8UC XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1 metformin ACTIVE MOIETY 9100L32L2N XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1 carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1 crospovidone INACTIVE INGREDIENT 68401960MK XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1 HYPROMELLOSE 2208 (100000 MPA.S) INACTIVE INGREDIENT VM7F0B23ZI XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-6250 XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] 38 Current NDC, Legacy NDC, 3 package rows 20250123_ac8a0f7b-9f69-4495-abbc-3a47cd75a859.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0310-6250-95 00310625095 1 BLISTER PACK in 1 CARTON (0310-6250-95) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 1 blister pack 2014-12-01 0000-00-00 Yes No Current