Sitagliptin and metformin hydrochloride

Product NDC: 70710-1987
11-digit product format: 707101987
Labeler code: 70710
Product ID: 70710-1987_6c6865d9-b997-4c50-bb00-0b188ae0d2c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sitagliptin and Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: NDA216743
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-03-14
Substance: SITAGLIPTIN; METFORMIN HYDROCHLORIDE
Active strength: 50; 1000 mg/1; mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 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 43.

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
N216743-001	ZITUVIMET	METFORMIN HYDROCHLORIDE; SITAGLIPTIN	500MG;50MG	TABLET / ORAL		RLD	2023-11-03
N216743-002	ZITUVIMET	METFORMIN HYDROCHLORIDE; SITAGLIPTIN	1GM;50MG	TABLET / ORAL		RLD, RS	2023-11-03

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216743-001	ZITUVIMET	500MG;50MG	TABLET / ORAL	RLD	2023-11-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216743-002	ZITUVIMET	1GM;50MG	TABLET / ORAL	RLD, RS	2023-11-03	`a50c72e98297…`

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: Sitagliptin and metformin hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SITAGLIPTIN	50 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
QFP0P1DV7Z	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
861769	Internal RxNorm lookup
861819	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
4d812277-21a8-4de3-b728-e3fdd01305b5	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
19a549d9-1cb9-4833-ba02-91db3dcb07ba	Product name	1	20251107
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
ff2e6e82-af62-4b84-b1ca-09520f6c5a79	Product name	1	20250630
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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
fd232072-39c4-4416-9b66-265d18a7bd93	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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
9fa860f8-41a8-caa8-93ae-a5bdc7b15db7	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70710-1987-6	Sitagliptin and metformin hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60		6
70710-1987-8	Sitagliptin and metformin hydrochloride	180 in 1 BOTTLE	TABLET, FILM COATED	180		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70710-1987-6	EA - Each	70710-1987	c1aef73f-9fb1-42ce-94d1-972b42fd8f34	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1987	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5	Current NDC, 2 package rows	20240810_4d812277-21a8-4de3-b728-e3fdd01305b5.zip

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
Sitagliptin and metformin hydrochloride	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	4d812277-21a8-4de3-b728-e3fdd01305b5	2026-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216743 application number: NDA216743 ndc (product): 70710-1987
Sitagliptin and metformin hydrochloride	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	e07abcb1-1f0c-4cad-8405-8eedba4b8ff8	2026-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216743 application number: NDA216743
ZITUVIMET	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	0098dec4-f0e5-45d5-8aa4-5d0faf9ab142	2026-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216743 application number: NDA216743
ZITUVIMET	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	eeda90a0-4941-4716-8684-f9f12cbdf3af	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216743 application number: NDA216743

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QFP0P1DV7Z	SITAGLIPTIN	486460-32-6	SITAGLIPTIN
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861769	SITagliptin 50 MG / metFORMIN HCl 1000 MG Oral Tablet	PSN	4d812277-21a8-4de3-b728-e3fdd01305b5	6
861819	SITagliptin 50 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	4d812277-21a8-4de3-b728-e3fdd01305b5	6
861769	metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet	SCD	4d812277-21a8-4de3-b728-e3fdd01305b5	6
861819	metformin hydrochloride 500 MG / sitagliptin 50 MG Oral Tablet	SCD	4d812277-21a8-4de3-b728-e3fdd01305b5	6
861769	metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet	SY	4d812277-21a8-4de3-b728-e3fdd01305b5	6
861819	metformin hydrochloride 500 MG / sitagliptin 50 MG Oral Tablet	SY	4d812277-21a8-4de3-b728-e3fdd01305b5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70710-1987-6	70710198706	60 TABLET, FILM COATED in 1 BOTTLE (70710-1987-6)	2024-03-14	No	No	Current
70710-1987-8	70710198708	180 TABLET, FILM COATED in 1 BOTTLE (70710-1987-8)	2024-03-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sitagliptin and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Global FZE \| Zydus Lifesciences Limited	2026-08-12	HUMAN PRESCRIPTION DRUG LABEL	7