Home NDC 0378-4705 Saxagliptin
Product NDC 0378-4705
11-digit product format 003784705
Labeler code 0378
Product ID 0378-4705_5844f950-ed79-43de-a6c4-2233878a9222
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name saxagliptin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA205980
Marketing category ANDA
Marketing start 2023-08-04
Substance SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
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 A205980-001 SAXAGLIPTIN SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 A205980-002 SAXAGLIPTIN SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB RS 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 2026-02-19 14:30 UTC 2026-02 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205980-001 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 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205980-001 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 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205980-001 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 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205980-001 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 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205980-001 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 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205980-001 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 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205980-001 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 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205980-001 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 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205980-001 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 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205980-001 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 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205980-001 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 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB 2023-07-31 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205980-001 SAXAGLIPTIN EQ 2.5MG BASE TABLET / ORAL AB 2023-07-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205980-002 SAXAGLIPTIN EQ 5MG BASE TABLET / ORAL AB RS 2023-07-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Saxagliptin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE 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 4N19ON48ZN 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 0378-4705-77 Saxagliptin 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 4 0378-4705-93 Saxagliptin 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-4705 SAXAGLIPTIN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 Current NDC, 2 package rows 20250322_6e8d8c4f-96eb-4b64-9c8c-4a5448a23a78.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0378-4705-77 00378470577 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-77) 2023-08-04 No No Current 0378-4705-93 00378470593 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-93) 2023-08-04 No No Current