Home NDC 0781-5801 Sitagliptin and Metformin Hydrochloride
Product NDC 0781-5801
11-digit product format 007815801
Labeler code 0781
Product ID 0781-5801_a0fcdc08-0afc-4912-a126-3efea6bc8c61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sitagliptin and Metformin Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA202388
Marketing category ANDA
Marketing start 2025-12-02
Substance SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
Active strength 50; 500 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS], 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 43 .
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 A202388-001 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 500MG;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 A202388-002 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 1GM;EQ 50MG BASE TABLET / ORAL AB 2025-12-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A202388-001 PC 2026-11-24 A202388-002 PC 2026-11-24
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 2026-09-14 22:38:34 2026-08 A202388-001 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 500MG;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202388-002 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 1GM;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202388-001 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 500MG;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202388-002 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 1GM;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202388-001 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 500MG;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202388-002 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 1GM;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202388-001 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 500MG;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202388-002 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 1GM;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202388-001 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 500MG;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202388-002 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 1GM;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 A202388-001 PC 2026-11-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202388-002 PC 2026-11-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202388-001 PC 2026-11-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202388-002 PC 2026-11-24 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202388-001 PC 2026-11-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202388-002 PC 2026-11-24 a50c72e98297…
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 Sitagliptin and Metformin Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SITAGLIPTIN PHOSPHATE 50 mg/1 METFORMIN HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 786Z46389E Internal UNII lookup TS63EW8X6F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2709488 Internal RxNorm lookup 2709491 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 0781-5801-05 Sitagliptin and Metformin Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 1 0781-5801-60 Sitagliptin and Metformin Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 1 0781-5801-71 Sitagliptin and Metformin Hydrochloride 180 in 1 BOTTLE TABLET, FILM COATED 180 1
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 0781-5801-05 00781580105 500 TABLET, FILM COATED in 1 BOTTLE (0781-5801-05) 2025-12-02 No No Current 0781-5801-60 00781580160 60 TABLET, FILM COATED in 1 BOTTLE (0781-5801-60) 2025-12-02 No No Current 0781-5801-71 00781580171 180 TABLET, FILM COATED in 1 BOTTLE (0781-5801-71) 2025-12-02 No No Current