Home NDC 0781-5801-71 Sitagliptin and Metformin Hydrochloride
Product NDC 0781-5801
Requested package NDC 0781-5801-71
11-digit product format 007815801
Labeler code 0781
Product ID 0781-5801_0861f6ba-7537-4d54-b2d2-86686639d0b8
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 2026-05-28
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 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 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 2026-11-14 07:37:17 2026-10 A202388-001 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 500MG;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A202388-002 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 1GM;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A202388-001 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 500MG;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202388-002 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 1GM;EQ 50MG BASE TABLET / ORAL AB 2025-12-02 c2088c7a36db…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# 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0781-5801-71 00781580171 180 TABLET, FILM COATED in 1 BOTTLE (0781-5801-71) 2026-05-28 No No Current