24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

RxCUI: 1593070
RxNorm name: 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
Display name: Dapagliflozin/metFORMIN XR (Oral Pill)
Full name: 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
Term type: SCD
Status: Active
Strength: 5-1,000 mg
Dose form: 24 HR XR Tab
Route: Oral Pill
Updated: 2026-10-15 14:49:19

RxNorm Status History#

Status: Active
Source: RXNORM
Current: YES
Release start: 122014
Active start: 122014
Multiple ingredient: YES
Branded: NO

Ingredients And Strength#

Ingredient, Strength, Base table
Ingredient	Strength	Base	Basis of strength
dapagliflozin propanediol	5 MG / 1 EACH	dapagliflozin	dapagliflozin
metformin hydrochloride	1000 MG / 1 EACH	metformin	metformin hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose form	RxCUI
Extended Release Oral Tablet	316945

Derived Ingredient Concepts#

Ingredient, RxCUI table
Ingredient	RxCUI
dapagliflozin	1488564
metformin	6809

Source Vocabulary Codes#

Code type, Values, Count table
Code type	Values	Count	Category
PRESCRIBABLE	Y	1	ATTRIBUTES
RXNAV_STR	24 HR dapagliflozin 5 MG / metFORMIN hydrochloride 1000 MG Extended Release Oral Tablet	1	NAMES
RxNorm Name	24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	1	NAMES
RxNorm Synonym	dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet	1	NAMES
TTY	SCD	1	ATTRIBUTES
SPL_SET_ID	8 linked values 4f890458-be94-4baf-b606-83a097e1e23e 7d575ca8-9c1f-469d-a341-34daf2f036dd 513bdf9f-774c-4f7f-935a-54d3885e80a4 54027b70-53e7-3710-e063-6394a90aa04c bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a e6957674-86c1-4536-8e23-54ad7f2cacc4 eadcc3ef-f5c2-4a56-a6aa-12909844144e eaf135b6-e378-4f62-a1e7-db45e23668c7	8	CODES
RxCUI	1593070	1	CODES
MMSL_CODE	2 linked values BD29968 CD29968	2	CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDC	Product NDC	Name	Labeler	Application
33342-408-06	33342-408	Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride	Macleods Pharmaceuticals Limited	ANDA211559
33342-408-07	33342-408	Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride	Macleods Pharmaceuticals Limited	ANDA211559
33342-408-09	33342-408	Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride	Macleods Pharmaceuticals Limited	ANDA211559
33342-408-10	33342-408	Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride	Macleods Pharmaceuticals Limited	ANDA211559
33342-408-15	33342-408	Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride	Macleods Pharmaceuticals Limited	ANDA211559
59651-155-04	59651-155	Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochloride	Aurobindo Pharma Limited	ANDA211489
59651-155-30	59651-155	Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochloride	Aurobindo Pharma Limited	ANDA211489
59651-155-60	59651-155	Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochloride	Aurobindo Pharma Limited	ANDA211489
63304-026-30	63304-026	Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA211491
63304-026-54	63304-026	Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA211491
63304-026-62	63304-026	Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA211491
66993-361-60	66993-361	dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloride	Prasco Laboratories	NDA205649
67877-620-30	67877-620	dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloride	Ascend Laboratories, LLC	ANDA211563
67877-620-60	67877-620	dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloride	Ascend Laboratories, LLC	ANDA211563
67877-620-90	67877-620	dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloride	Ascend Laboratories, LLC	ANDA211563
70748-102-07	70748-102	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	ANDA211579
72205-435-01	72205-435	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	ANDA211479
72205-435-02	72205-435	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	ANDA211479
72205-435-03	72205-435	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	ANDA211479
84677-020-60	84677-020	Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride	Golden State Medical Supply, Inc.	ANDA211491

Drugs@FDA Applications#

Application, NDC, Name table
Application	NDC	Name	Marketing category	Labeler
ANDA211559	33342-408	Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride	ANDA	Macleods Pharmaceuticals Limited
ANDA211489	59651-155	Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochloride	ANDA	Aurobindo Pharma Limited
ANDA211491	63304-026	Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride	ANDA	Sun Pharmaceutical Industries, Inc.
NDA205649	66993-361	dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloride	NDA AUTHORIZED GENERIC	Prasco Laboratories
ANDA211563	67877-620	dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloride	ANDA	Ascend Laboratories, LLC
ANDA211579	70748-102	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	ANDA	Lupin Pharmaceuticals, Inc.
ANDA211479	72205-435	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	ANDA	Novadoz Pharmaceuticals LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 21 matching rows.

NDC11, Source, Active table
NDC11	Source	Active
33342040806	rxnav_ndcs	yes
33342040807	rxnav_ndcs	yes
33342040809	rxnav_ndcs	yes
33342040810	rxnav_ndcs	yes
33342040815	rxnav_ndcs	yes
33342040866	rxnav_ndcs	yes
59651015504	rxnav_ndcs	yes
59651015530	rxnav_ndcs	yes
59651015560	rxnav_ndcs	yes
63304002630	rxnav_ndcs	yes
63304002654	rxnav_ndcs	yes
63304002662	rxnav_ndcs	yes
66993036160	rxnav_ndcs	yes
67877062030	rxnav_ndcs	yes
67877062060	rxnav_ndcs	yes
67877062090	rxnav_ndcs	yes
70748010207	rxnav_ndcs	yes
72205043501	rxnav_ndcs	yes
72205043502	rxnav_ndcs	yes
72205043503	rxnav_ndcs	yes
84677002060	rxnav_ndcs	yes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XIGDUO XR	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1593070
Dapagliflozin and Metformin Hydrochloride	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	54027b70-53e7-3710-e063-6394a90aa04c	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 84677-020-60 ndc (product): 84677-020 ndc11 (package): 84677002060 rxcui: 1593070
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	4f890458-be94-4baf-b606-83a097e1e23e	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 72205-435-03 ndc (package): 72205-435-02 ndc (package): 72205-435-01 ndc (product): 72205-435 ndc11 (package): 72205043502 ndc11 (package): 72205043503 ndc11 (package): 72205043501 rxcui: 1593070
dapagliflozin and metformin hydrochloride	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC	eadcc3ef-f5c2-4a56-a6aa-12909844144e	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 67877-620-60 ndc (package): 67877-620-30 ndc (package): 67877-620-90 ndc (product): 67877-620 ndc11 (package): 67877062060 ndc11 (package): 67877062030 ndc11 (package): 67877062090 rxcui: 1593070

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 8 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
ac8a0f7b-9f69-4495-abbc-3a47cd75a859	dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]	3	38	These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full prescribing information for XIGDUO XR. XIGDUO ® XR (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral use Initial U.S. Approval: 2014	20241220
e6957674-86c1-4536-8e23-54ad7f2cacc4	dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]	3	15	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	20260421
eadcc3ef-f5c2-4a56-a6aa-12909844144e	dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]	3	14	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	20260318
eaf135b6-e378-4f62-a1e7-db45e23668c7	dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]	3	7	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED‑RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED‑RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED‑RELEASE tablets, for oral use Initial U.S. Approval: 2014	20241220
bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a	dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]	3	2	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended release tablets, for oral use Initial U.S. Approval: 2014	20260331
4f890458-be94-4baf-b606-83a097e1e23e	dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]	3	1	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HCL EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HCL EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	20260409
513bdf9f-774c-4f7f-935a-54d3885e80a4	dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]	3	1	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	20260407
7d575ca8-9c1f-469d-a341-34daf2f036dd	dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]	3	1	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	20260331

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set ID	Title	Manufacturer	Effective
bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	Sun Pharmaceutical Industries, Inc. \| Ohm Laboratories Inc.	20260917
7d575ca8-9c1f-469d-a341-34daf2f036dd	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	Macleods Pharmaceuticals Limited	20260916
e6957674-86c1-4536-8e23-54ad7f2cacc4	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	20260908
513bdf9f-774c-4f7f-935a-54d3885e80a4	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	20260902
eaf135b6-e378-4f62-a1e7-db45e23668c7	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED‑RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED‑RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED‑RELEASE tablets, for oral use Initial U.S. Approval: 2014	Prasco Laboratories \| AstraZeneca PLC \| AstraZeneca Pharmaceuticals LP	20260801
54027b70-53e7-3710-e063-6394a90aa04c	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS. These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended release tablets, for oral use Initial U.S. Approval: 2014	Golden State Medical Supply, Inc.	20260611
e6957674-86c1-4536-8e23-54ad7f2cacc4	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	20260421
4f890458-be94-4baf-b606-83a097e1e23e	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HCL EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HCL EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	Novadoz Pharmaceuticals LLC \| MSN LABORATORIES PRIVATE LIMITED	20260409
513bdf9f-774c-4f7f-935a-54d3885e80a4	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	20260407
bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended release tablets, for oral use Initial U.S. Approval: 2014	Sun Pharmaceutical Industries, Inc.	20260331
7d575ca8-9c1f-469d-a341-34daf2f036dd	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	Macleods Pharmaceuticals Limited	20260331
eadcc3ef-f5c2-4a56-a6aa-12909844144e	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014	Ascend Laboratories, LLC \| Alkem Laboratories Limited	20260318
eaf135b6-e378-4f62-a1e7-db45e23668c7	These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED‑RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED‑RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED‑RELEASE tablets, for oral use Initial U.S. Approval: 2014	Prasco Laboratories \| AstraZeneca PLC	20241220

Drug Classes#

Source, Class ID, Class table
Source	Class ID	Class	Type	Relationship	Drug concept
ATC	A10BA	Biguanides	ATC1-4		metformin
ATC	A10BD	Combinations of oral blood glucose lowering drugs	ATC1-4		dapagliflozin / metformin
ATC	A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors	ATC1-4		dapagliflozin
FDASPL	D001645	Biguanides	CHEM	has_chemical_structure	metformin
FDASPL	N0000175565	Biguanide	EPC	has_epc	metformin
FDASPL	N0000187059	Sodium-Glucose Cotransporter 2 Inhibitor	EPC	has_epc	dapagliflozin
FDASPL	N0000187058	Sodium-Glucose Transporter 2 Inhibitors	MOA	has_moa	dapagliflozin
MEDRT	D001559	Benzhydryl Compounds	CHEM	has_ingredient	dapagliflozin
MEDRT	D005960	Glucosides	CHEM	has_ingredient	dapagliflozin
MEDRT	D008687	Metformin	CHEM	has_ingredient	metformin
MEDRT	D008687	Metformin	CHEM	has_ingredient	metformin hydrochloride
MEDRT	D000138	Acidosis	DISEASE	ci_with	metformin hydrochloride
MEDRT	D000138	Acidosis	DISEASE	ci_with	metformin
MEDRT	D003924	Diabetes Mellitus, Type 2	DISEASE	may_treat	metformin
MEDRT	D003924	Diabetes Mellitus, Type 2	DISEASE	may_treat	dapagliflozin
MEDRT	D003924	Diabetes Mellitus, Type 2	DISEASE	may_treat	metformin hydrochloride
MEDRT	D016883	Diabetic Ketoacidosis	DISEASE	ci_with	metformin
MEDRT	D016883	Diabetic Ketoacidosis	DISEASE	ci_with	metformin hydrochloride
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	metformin hydrochloride
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	metformin
MEDRT	D006333	Heart Failure	DISEASE	may_treat	dapagliflozin
MEDRT	D008107	Liver Diseases	DISEASE	ci_with	metformin hydrochloride
MEDRT	D008107	Liver Diseases	DISEASE	ci_with	metformin
MEDRT	D051437	Renal Insufficiency	DISEASE	ci_with	metformin hydrochloride
MEDRT	D051437	Renal Insufficiency	DISEASE	ci_with	metformin
MEDRT	N0000000225	Insulin Receptor Agonists	MOA	has_moa	metformin
MEDRT	N0000000225	Insulin Receptor Agonists	MOA	has_moa	metformin hydrochloride
MEDRT	N0000187058	Sodium-Glucose Transporter 2 Inhibitors	MOA	has_moa	dapagliflozin
MEDRT	N0000008646	Decreased Gluconeogenesis	PE	has_pe	metformin hydrochloride
MEDRT	N0000008646	Decreased Gluconeogenesis	PE	has_pe	metformin
MEDRT	N0000008650	Decreased Glycogenesis	PE	has_pe	metformin
MEDRT	N0000008650	Decreased Glycogenesis	PE	has_pe	metformin hydrochloride
MEDRT	N0000175650	Decreased Sympathetic Activity	PE	has_pe	dapagliflozin
MEDRT	N0000009341	Increased Glucose Transport into Cells	PE	has_pe	metformin hydrochloride
MEDRT	N0000009341	Increased Glucose Transport into Cells	PE	has_pe	metformin
MEDRT	N0000009556	Increased Renal Organic Ion Excretion	PE	has_pe	dapagliflozin
MEDRT	N0000009830	Renal Ion Transport Alteration	PE	has_pe	dapagliflozin
MEDRT	N0000000042	Renal Excretion	PK	has_pk	metformin
MEDRT	N0000000042	Renal Excretion	PK	has_pk	metformin hydrochloride

Group, Type, Concept table
Group	Type	Concept	Source
BN	BN	Xigduo	rxnav_allrelated
DF	DF	Extended Release Oral Tablet	rxnav_allrelated
DFG	DFG	Oral Product	rxnav_allrelated
DFG	DFG	Pill	rxnav_allrelated
IN	IN	dapagliflozin	rxnav_allrelated
IN	IN	metformin	rxnav_allrelated
MIN	MIN	dapagliflozin / metformin	rxnav_allrelated
PIN	PIN	metformin hydrochloride	rxnav_allrelated
SBD	SBD	24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo]	rxnav_allrelated
SBDC	SBDC	dapagliflozin 5 MG / metformin hydrochloride 1000 MG [Xigduo]	rxnav_allrelated
SBDF	SBDF	dapagliflozin / metformin Extended Release Oral Tablet [Xigduo]	rxnav_allrelated
SBDFP	SBDFP	dapagliflozin / metformin hydrochloride Extended Release Oral Tablet [Xigduo]	rxnav_allrelated
SBDG	SBDG	Xigduo Oral Product	rxnav_allrelated
SBDG	SBDG	Xigduo Pill	rxnav_allrelated
SCD	SCD	24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	rxnav_allrelated
SCDC	SCDC	dapagliflozin 5 MG	rxnav_allrelated
SCDC	SCDC	metformin hydrochloride 1000 MG	rxnav_allrelated
SCDF	SCDF	dapagliflozin / metformin Extended Release Oral Tablet	rxnav_allrelated
SCDFP	SCDFP	dapagliflozin / metformin hydrochloride Extended Release Oral Tablet	rxnav_allrelated
SCDG	SCDG	dapagliflozin / metformin Oral Product	rxnav_allrelated
SCDG	SCDG	dapagliflozin / metformin Pill	rxnav_allrelated
SCDGP	SCDGP	dapagliflozin / metformin hydrochloride Oral Product	rxnav_allrelated
SCDGP	SCDGP	dapagliflozin / metformin hydrochloride Pill	rxnav_allrelated

Properties#

Category, Property, Value table
Category	Property	Value
ATTRIBUTES	AVAILABLE_STRENGTH	5 MG / 1000 MG
ATTRIBUTES	GENERAL_CARDINALITY	MULTI
ATTRIBUTES	HUMAN_DRUG	US
ATTRIBUTES	QUANTITY	24 HR
ATTRIBUTES	RXNAV_HUMAN_DRUG	US
ATTRIBUTES	SCHEDULE	0
CODES	ANDA	ANDA211479
CODES	ANDA	ANDA211489
CODES	ANDA	ANDA211491
CODES	ANDA	ANDA211559
CODES	ANDA	ANDA211563
CODES	ANDA	ANDA211579
CODES	VUID	4033847
NAMES	Prescribable Synonym	dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
NAMES	Tallman Synonym	24 HR dapagliflozin 5 MG / metFORMIN hydrochloride 1000 MG Extended Release Oral Tablet
NAMES	Tallman Synonym	dapagliflozin (as dapagliflozin propanediol) 5 MG / metFORMIN hydrochloride 1000 MG 24 HR Extended Release Oral Tablet
SOURCES	Source	Gold Standard Alchemy
SOURCES	Source	Metathesaurus FDA Structured Product Labels
SOURCES	Source	Micromedex RED BOOK
SOURCES	Source	Multum MediSource Lexicon
SOURCES	Source	National Drug Data File Plus Source Vocabulary
SOURCES	Source	Veterans Health Administration National Drug File