Home NDC 0310-6100-90 ONGLYZA
Product NDC 0310-6100
Requested package NDC 0310-6100-90
11-digit product format 003106100
Labeler code 0310
Product ID 0310-6100_faa525bd-c66c-4c61-8edb-d5985e388d63
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SAXAGLIPTIN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA022350
Marketing category NDA
Marketing start 2014-11-20
Marketing end 0000-00-00
Substance SAXAGLIPTIN HYDROCHLORIDE
Active strength 3 mg/1
Pharmacologic classes Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 N022350-001 ONGLYZA SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 N022350-002 ONGLYZA SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022350-001 7951400 2028-11-30 Drug product 2011-06-29 N022350-002 7951400 2028-11-30 Drug product
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N022350-001 M-14 2027-10-11 N022350-002 M-14 2027-10-11
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 3 · 86 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 2026-09-14 22:38:34 2026-08 N022350-001 ONGLYZA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022350-002 ONGLYZA EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022350-001 ONGLYZA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022350-002 ONGLYZA EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022350-001 ONGLYZA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022350-002 ONGLYZA EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022350-001 ONGLYZA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022350-002 ONGLYZA EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022350-001 ONGLYZA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022350-002 ONGLYZA EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022350-001 ONGLYZA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022350-002 ONGLYZA EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022350-001 ONGLYZA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022350-002 ONGLYZA EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022350-001 ONGLYZA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022350-002 ONGLYZA EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD 2009-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD 2009-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD 2009-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD 2009-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD 2009-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD 2009-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD 2009-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD 2009-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD, RS 2009-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD, RS 2009-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD, RS 2009-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022350-001 ONGLYZA EQ 2.5MG BASE TABLET / ORAL RLD 2009-07-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022350-002 ONGLYZA EQ 5MG BASE TABLET / ORAL RLD, RS 2009-07-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022350-001 AB 1 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022350-002 AB 1 9b2671bbb829…
Observed Orange Book patent history# Patent history page 1 of 5 · 182 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022350-002 7951400 2028-11-30 Drug product 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022350-002 7951400 2028-11-30 Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022350-002 7951400 2028-11-30 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022350-002 7951400 2028-11-30 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022350-002 7951400 2028-11-30 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022350-002 7951400 2028-11-30 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022350-002 7951400 2028-11-30 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022350-002 7951400 2028-11-30 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022350-002 7951400 2028-11-30 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022350-002 7951400 2028-11-30 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022350-002 7951400 2028-11-30 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022350-002 7951400 2028-11-30 Drug product d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022350-002 7951400 2028-11-30 Drug product 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022350-002 7951400 2028-11-30 Drug product 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022350-002 7951400 2028-11-30 Drug product 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022350-002 7951400 2028-11-30 Drug product 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022350-001 RE44186 2023-07-31 U-1837 Drug substance, Drug product 2013-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022350-001 RE44186 2023-07-31 U-995 Drug substance, Drug product 2013-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022350-002 RE44186 2023-07-31 U-995 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022350-002 RE44186 2023-07-31 U-1837 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022350-002 7951400 2028-11-30 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022350-001 RE44186 2023-07-31 U-1837 Drug substance, Drug product 2013-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022350-001 RE44186 2023-07-31 U-995 Drug substance, Drug product 2013-05-24 5d02ea3f76ae…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-6100 ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 26 Legacy NDC 20241019_c5116390-e0fe-4969-94cb-e9de5165fbab.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0310-6100-90 00310610090 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-90) 2015-01-06 0000-00-00 No No Current