FDA.reportPublic FDA data

SITAGLIPTIN PHOSPHATE - METFORMIN HYDROCHLORIDE, TABLETS

Manufacturer
Patheon Puerto Rico, Inc.
Effective date
2016-04-29
Label type
BULK INGREDIENT
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:27:10

Label at a glance#

ProductSitagliptin Phosphate/Metformin Hydrochloride
Active ingredientSITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - Shipping Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SITAGLIPTIN PHOSPHATE - METFORMIN HYDROCHLORIDE,
TABLETS 50mg / 850mg

Store Conditions: Storage below 25°C

Cautions:
Health: 3
Flammability: 2
Reactivity: 2
Personal Protective Equipment: K

Manufactured by: PATHEON PUERTO RICO, INC.
STATE ROAD 670 KM 2.7
MANATI, PUERTO RICO 00674

Distributed by: MERCK & CO., INC

Lot: XXXXXXXX
Mgf. Date: MMM DD YY
Quantity: XXX Kg

Shipping Label
Shipping Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55370-00655370-006-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SITAGLIPTIN PHOSPHATETS63EW8X6FACTIB
METFORMIN HYDROCHLORIDE786Z46389EACTIB
FERROSOFERRIC OXIDEXM0M87F357IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL532B59J990IACT
POVIDONE K29/32390RMW2PEQIACT
FERRIC OXIDE RED1K09F3G675IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sitagliptin PhosphateSITAGLIPTIN PHOSPHATESandoz Inccebc8388-c9db-4e27-8d6b-0d9bdc9d766d2026-05-10Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN PHOSPHATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.