Home NDC 70710-1242 ZITUVIO
Product NDC 70710-1242
11-digit product format 707101242
Labeler code 70710
Product ID 70710-1242_1686e1de-8172-444b-a267-ad3bc7ca69f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sitagliptin
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
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 1 .
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 TE codes 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 Use code 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 · 57 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 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211566-002 ZITUVIO 50MG TABLET / ORAL RLD 2023-10-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211566-003 ZITUVIO 100MG TABLET / ORAL RLD, RS 2023-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211566-001 ZITUVIO 25MG TABLET / ORAL RLD 2023-10-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211566-002 ZITUVIO 50MG TABLET / ORAL RLD 2023-10-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211566-003 ZITUVIO 100MG TABLET / ORAL RLD, RS 2023-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211566-001 ZITUVIO 25MG TABLET / ORAL RLD 2023-10-18 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 2 · 51 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211566-002 10925871 2035-02-25 Drug product 2023-12-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211566-003 10925871 2035-02-25 Drug product 2023-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211566-001 10925871 2035-02-25 Drug product 2023-12-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211566-002 10925871 2035-02-25 Drug product 2023-12-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211566-003 10925871 2035-02-25 Drug product 2023-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211566-001 10925871 2035-02-25 Drug product 2023-12-18 8072bd15b7f6…
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70710-1242-3 ZITUVIO 30 in 1 BOTTLE TABLET 30 7 70710-1242-9 ZITUVIO 90 in 1 BOTTLE TABLET 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1242 ZITUVIO (SITAGLIPTIN) TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 Current NDC, 2 package rows 20250201_abfdea45-c0ca-41e3-a510-e89810bc9cfe.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70710-1242-3 70710124203 30 TABLET in 1 BOTTLE (70710-1242-3) 30 tablet 2023-11-30 No No Current 70710-1242-9 70710124209 90 TABLET in 1 BOTTLE (70710-1242-9) 90 tablet 2023-11-30 No No Current