dapagliflozin and metformin hydrochloride

Product NDC: 66993-361
11-digit product format: 669930361
Labeler code: 66993
Product ID: 66993-361_8954a9fe-fbb8-4d24-949a-85ae4bfb7ba5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dapagliflozin and metformin hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Prasco Laboratories
Application: NDA205649
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-01-03
Substance: DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE
Active strength: 5; 1000 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.

Application-product, TE code table
Application-product	TE code
N205649-001	AB
N205649-002	AB
N205649-003	AB
N205649-004	AB
N205649-005	AB

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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205649-001	NPP	2027-06-12
N205649-001	PED	2027-12-12
N205649-002	NPP	2027-06-12
N205649-002	PED	2027-12-12
N205649-003	NPP	2027-06-12
N205649-003	PED	2027-12-12
N205649-004	NPP	2027-06-12
N205649-004	PED	2027-12-12
N205649-005	NPP	2027-06-12
N205649-005	PED	2027-12-12

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	N205649-001	XIGDUO XR	5MG;500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	XIGDUO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	XIGDUO XR	10MG;500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	XIGDUO XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-005	XIGDUO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-07-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N205649-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-005	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 50 observed states.

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	N205649-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-001	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-001	8501698	2027-06-20	U-493	Drug product	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-001	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-001	7919598	2029-12-16		Drug substance	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-001	8685934	2030-05-26	U-1522		2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-001	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-001	9616028	2030-11-12		Drug product	2017-08-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-001	8685934*PED	2030-11-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-001	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	8501698	2027-06-20	U-493	Drug product	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	7919598	2029-12-16		Drug substance	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	8685934	2030-05-26	U-1522		2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	9616028	2030-11-12		Drug product	2017-08-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	8685934*PED	2030-11-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	8501698	2027-06-20	U-493	Drug product	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	7919598	2029-12-16		Drug substance	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	8685934	2030-05-26	U-1522		2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	9616028	2030-11-12		Drug product	2017-08-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	8685934*PED	2030-11-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	8501698	2027-06-20	U-493	Drug product	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	7919598	2029-12-16		Drug substance	2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	8685934	2030-05-26	U-1522		2014-11-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	9616028	2030-11-12		Drug product	2017-08-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	8685934*PED	2030-11-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N205649-001	NPP	2027-06-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-001	PED	2027-12-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	NPP	2027-06-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-002	PED	2027-12-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	NPP	2027-06-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-003	PED	2027-12-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	NPP	2027-06-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-004	PED	2027-12-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-005	NPP	2027-06-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205649-005	PED	2027-12-12	`a50c72e98297…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dapagliflozin and metformin hydrochloride	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Prasco Laboratories	eaf135b6-e378-4f62-a1e7-db45e23668c7	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205649 application number: NDA205649 ndc (product): 66993-361
XIGDUO XR	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205649 application number: NDA205649

Additional Listing Data#

Finished product: Yes
Brand name base: dapagliflozin and metformin hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DAPAGLIFLOZIN PROPANEDIOL	5 mg/1
METFORMIN HYDROCHLORIDE	1000 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1593058	Internal RxNorm lookup
1593070	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
eaf135b6-e378-4f62-a1e7-db45e23668c7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
c30aab5e-c89f-4b59-83b1-99a940b63351	Product name	1	20200925
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
85b4e38c-4488-4e48-919e-244e107d9bd9	Product name	2	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66993-361-60	dapagliflozin and metformin hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-361-60	EA - Each	66993-361	054a74fd-e9f1-40f5-b32f-5eac8d8434ed	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-361	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO, LLC]	6	Current NDC, 1 package rows	20250123_eaf135b6-e378-4f62-a1e7-db45e23668c7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
887K2391VH	DAPAGLIFLOZIN PROPANEDIOL	960404-48-2	DAPAGLIFLOZIN PROPANEDIOL
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1593058	dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	eaf135b6-e378-4f62-a1e7-db45e23668c7	7
1593070	dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	eaf135b6-e378-4f62-a1e7-db45e23668c7	7
1593058	24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	eaf135b6-e378-4f62-a1e7-db45e23668c7	7
1593070	24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	eaf135b6-e378-4f62-a1e7-db45e23668c7	7
1593058	dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet	SY	eaf135b6-e378-4f62-a1e7-db45e23668c7	7
1593070	dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet	SY	eaf135b6-e378-4f62-a1e7-db45e23668c7	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
66993-361-60	66993036160	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-361-60)	2024-01-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
dapagliflozin and metformin hydrochloride	Prasco Laboratories \| AstraZeneca PLC	2024-12-20	HUMAN PRESCRIPTION DRUG LABEL	7