Home NDC 65862-825 Saxagliptin
Product NDC 65862-825
11-digit product format 658620825
Labeler code 65862
Product ID 65862-825_ac9f5784-0c62-42f2-bc34-4cef2486b7f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Saxagliptin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA205972
Marketing category ANDA
Marketing start 2023-07-31
Substance SAXAGLIPTIN HYDROCHLORIDE
Active strength 2.5 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205972-001 SAXAGLIPTIN SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 A205972-002 SAXAGLIPTIN SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A205972-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A205972-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Saxagliptin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SAXAGLIPTIN HYDROCHLORIDE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z8J84YIX6L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858036 Internal RxNorm lookup 858042 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 65862-825-01 Saxagliptin 100 in 1 BOTTLE TABLET, FILM COATED 100 3 65862-825-05 Saxagliptin 500 in 1 BOTTLE TABLET, FILM COATED 500 3 65862-825-30 Saxagliptin 30 in 1 BOTTLE TABLET, FILM COATED 30 3 65862-825-90 Saxagliptin 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-825 SAXAGLIPTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 3 Current NDC, 4 package rows 20241212_f3ea58bb-0002-4a5d-9213-7e9066e3dc9c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 65862-825-01 65862082501 100 TABLET, FILM COATED in 1 BOTTLE (65862-825-01) 2023-07-31 No No Current 65862-825-05 65862082505 500 TABLET, FILM COATED in 1 BOTTLE (65862-825-05) 2023-07-31 No No Current 65862-825-30 65862082530 30 TABLET, FILM COATED in 1 BOTTLE (65862-825-30) 2023-07-31 No No Current 65862-825-90 65862082590 90 TABLET, FILM COATED in 1 BOTTLE (65862-825-90) 2023-07-31 No No Current