515 Pill — PINK OVAL, 20mm — Sitagliptin

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Imprint515
ColourPINK
ShapeOVAL
Size20
StrengthSITAGLIPTIN PHOSPHATE 50 mg;METFORMIN HYDROCHLORIDE 850 mg
Dosage formTablet, Film Coated
ManufacturerPatheon Puerto Rico, Inc.
NDC55370-006
Schedule—
AvailabilityDrug For Further Processing
IngredientsSITAGLIPTIN PHOSPHATE[SITAGLIPTIN];METFORMIN HYDROCHLORIDE[METFORMIN]

What does this imprint mean?

The imprint "515" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Sitagliptin

Uses and warnings

Pancreatitis - "postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis"; Heart Failure - association observed with DPP-4 inhibitors in cardiovascular trials; Acute Renal Failure - "postmarketing reports of worsening renal function, including acute renal failure"; Hypoglycemia risk increased when combined with insulin or insulin secretagogues; Hypersensitivity Reactions including anaphylaxis, angioedema, Stevens-Johnson syndrome; Arthralgia - severe joint pain reported with DPP-4 inhibitors; Bullous Pemphigoid, a blistering condition requiring hospitalization.

"JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus." Not for type 1 diabetes or patients with pancreatitis history.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 54b46e01-d8aa-40e7-9bc6-234831f20ef2.xml