Home NDC 0310-6105 ONGLYZA
Product NDC 0310-6105
11-digit product format 003106105
Labeler code 0310
Product ID 0310-6105_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 5 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 1 .
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ONGLYZA SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 N022350-002 ONGLYZA SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31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
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 N022350-001 ONGLYZA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N022350-002 ONGLYZA EQ 5MG BASE **Federal Register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 a50c72e98297…
Observed Orange Book patent history# 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 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N022350-002 7951400 2028-11-30 Drug product a50c72e98297…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded saxagliptin hydrochloride ACTIVE INGREDIENT Z8J84YIX6L ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 4 saxagliptin anhydrous ACTIVE MOIETY 8I7IO46IVQ ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 4 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 4 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 4 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 4 saxagliptin hydrochloride ACTIVE INGREDIENT Z8J84YIX6L ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] 1 saxagliptin anhydrous ACTIVE MOIETY 8I7IO46IVQ ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-6105 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 Units Marketing start Marketing end Sample Exclude flag Status 0310-6105-30 00310610530 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-30) 2014-12-18 0000-00-00 No No Current 0310-6105-90 00310610590 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-90) 2014-12-19 0000-00-00 No No Current 0310-6105-95 00310610595 1 BLISTER PACK in 1 CARTON (0310-6105-95) > 7 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2015-08-15 0000-00-00 No No Current