Home NDC 55154-6931-2 ONGLYZA
Product NDC 55154-6931
Requested package NDC 55154-6931-2
11-digit product format 551546931
Labeler code 55154
Product ID 55154-6931_048ab1ca-6e74-49ad-9a9e-c866a2b9ce01
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SAXAGLIPTIN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health 107, LLC
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 2023-12-31
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ONGLYZA SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 N022350-002 ONGLYZA SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31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N022350-001 ONGLYZA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N022350-002 ONGLYZA EQ 5MG BASE **Federal Register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 Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-6931 ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] 12 Legacy NDC 20241010_e4f2a84f-5117-4738-b769-aba8debbddb0.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55154-6931-2 55154693102 1080 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-6931-2) 2014-11-20 0000-00-00 No No Current