Home NDC 65862-826-90 Saxagliptin
Product NDC 65862-826
Requested package NDC 65862-826-90
11-digit product format 658620826
Labeler code 65862
Product ID 65862-826_e040cdab-da80-4b2c-a024-4b39d41f8ffb
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 5 mg/1
Pharmacologic classes Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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.
Product history page 1 of 2 · 48 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 2026-11-14 07:37:17 2026-10 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205972-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A205972-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Saxagliptin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SAXAGLIPTIN HYDROCHLORIDE 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 65862-826-01 Saxagliptin 100 in 1 BOTTLE TABLET, FILM COATED 100 3 65862-826-05 Saxagliptin 500 in 1 BOTTLE TABLET, FILM COATED 500 3 65862-826-30 Saxagliptin 30 in 1 BOTTLE TABLET, FILM COATED 30 3 65862-826-90 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 65862-826 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 65862-826-90 65862082690 90 TABLET, FILM COATED in 1 BOTTLE (65862-826-90) 2023-07-31 No No Current