ZITUVIO

Product NDC: 70771-1772
11-digit product format: 707711772
Labeler code: 70771
Product ID: 70771-1772_938530d0-f5ca-451d-a8d4-55384ae75e20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sitagliptin
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: NDA211566
Marketing category: NDA
Marketing start: 2023-11-30
Substance: SITAGLIPTIN
Active strength: 100 mg/1
Pharmacologic classes: Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N211566-001	ZITUVIO	SITAGLIPTIN	25MG	TABLET / ORAL	RLD	2023-10-18
N211566-002	ZITUVIO	SITAGLIPTIN	50MG	TABLET / ORAL	RLD	2023-10-18
N211566-003	ZITUVIO	SITAGLIPTIN	100MG	TABLET / ORAL	RLD, RS	2023-10-18

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N211566-001	10925871	2035-02-25	Drug product	2023-12-18
N211566-002	10925871	2035-02-25	Drug product	2023-12-18
N211566-003	10925871	2035-02-25	Drug product	2023-12-18

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 2 · 63 observed 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	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211566-002	ZITUVIO	50MG	TABLET / ORAL	RLD	2023-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211566-003	ZITUVIO	100MG	TABLET / ORAL	RLD, RS	2023-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211566-001	ZITUVIO	25MG	TABLET / ORAL	RLD	2023-10-18	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211566-002	10925871	2035-02-25	Drug product	2023-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211566-003	10925871	2035-02-25	Drug product	2023-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211566-001	10925871	2035-02-25	Drug product	2023-12-18	`301d65b070ca…`

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: ZITUVIO
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SITAGLIPTIN	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QFP0P1DV7Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
665033	Internal RxNorm lookup
665038	Internal RxNorm lookup
665042	Internal RxNorm lookup
2670447	Internal RxNorm lookup
2670449	Internal RxNorm lookup
2670451	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
b2da9d77-154b-48f7-8793-3f4a24dfafc6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
fd232072-39c4-4416-9b66-265d18a7bd93	Product name	1	20180306
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
9fa860f8-41a8-caa8-93ae-a5bdc7b15db7	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
70771-1772-3	ZITUVIO	30 in 1 BOTTLE	TABLET	30		6
70771-1772-9	ZITUVIO	90 in 1 BOTTLE	TABLET	90		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1772	ZITUVIO (SITAGLIPTIN) TABLET [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, 2 package rows	20250201_b2da9d77-154b-48f7-8793-3f4a24dfafc6.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
ZITUVIO	SITAGLIPTIN	Zydus Pharmaceuticals (USA) Inc.	abfdea45-c0ca-41e3-a510-e89810bc9cfe	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211566 application number: NDA211566
ZITUVIO	SITAGLIPTIN	Zydus Lifesciences Limited	b2da9d77-154b-48f7-8793-3f4a24dfafc6	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211566 application number: NDA211566 ndc (product): 70771-1772
Sitagliptin	SITAGLIPTIN	Zydus Pharmaceuticals (USA) Inc.	6a970e80-b753-48fa-9fff-87e7a5044982	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211566 application number: NDA211566
Sitagliptin	SITAGLIPTIN	Zydus Lifesciences Limited	e5ac97e8-3a0b-4750-8e3f-337412570746	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211566 application number: NDA211566

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QFP0P1DV7Z	SITAGLIPTIN	486460-32-6	SITAGLIPTIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
665033	SITagliptin 100 MG Oral Tablet	PSN	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
665038	SITagliptin 25 MG Oral Tablet	PSN	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
665042	SITagliptin 50 MG Oral Tablet	PSN	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
2670447	Zituvio 100 MG Oral Tablet	PSN	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
2670449	Zituvio 25 MG Oral Tablet	PSN	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
2670451	Zituvio 50 MG Oral Tablet	PSN	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
2670447	sitagliptin 100 MG Oral Tablet [Zituvio]	SBD	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
2670449	sitagliptin 25 MG Oral Tablet [Zituvio]	SBD	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
2670451	sitagliptin 50 MG Oral Tablet [Zituvio]	SBD	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
665033	sitagliptin 100 MG Oral Tablet	SCD	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
665038	sitagliptin 25 MG Oral Tablet	SCD	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
665042	sitagliptin 50 MG Oral Tablet	SCD	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
2670447	Zituvio 100 MG Oral Tablet	SY	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
2670449	Zituvio 25 MG Oral Tablet	SY	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6
2670451	Zituvio 50 MG Oral Tablet	SY	b2da9d77-154b-48f7-8793-3f4a24dfafc6	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70771-1772-3	70771177203	30 TABLET in 1 BOTTLE (70771-1772-3)	30 tablet	2023-11-30	No	No	Current
70771-1772-9	70771177209	90 TABLET in 1 BOTTLE (70771-1772-9)	90 tablet	2023-11-30	No	No	Current