SITAGLIPTIN PHOSPHATE - METFORMIN HYDROCHLORIDE, TABLETS

Sitagliptin Phosphate/Metformin Hydrochloride by

Drug Labeling and Warnings

Sitagliptin Phosphate/Metformin Hydrochloride by is a Other medication manufactured, distributed, or labeled by Patheon Puerto Rico, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SITAGLIPTIN PHOSPHATE/METFORMIN HYDROCHLORIDE- sitagliptin and metformin hydrochloride tablet, film coated 
Patheon Puerto Rico, Inc.

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SITAGLIPTIN PHOSPHATE - METFORMIN HYDROCHLORIDE, TABLETS

PRINCIPAL DISPLAY PANEL - Shipping Label

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

SITAGLIPTIN PHOSPHATE/METFORMIN HYDROCHLORIDE 
sitagliptin and metformin hydrochloride tablet, film coated

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 55370-006

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z)	SITAGLIPTIN PHOSPHATE	50 mg
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	850 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE K29/32 (UNII: 390RMW2PEQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (pink)	Score	no score
Shape	OVAL (capsule-shaped)	Size	20mm
Flavor		Imprint Code	515
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55370-006-00	22381 in 1 CONTAINER	03/30/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		03/30/2007

Labeler - Patheon Puerto Rico, Inc. (174050377)

Establishment
Name	Address	ID/FEI	Business Operations
Patheon Puerto Rico, Inc.		143814544	manufacture(55370-006)

Revised: 4/2016

Document Id: 54b46e01-d8aa-40e7-9bc6-234831f20ef2

Set id: a352f7d4-a907-4617-baac-5f165c39437b

Version: 1

Effective Time: 20160429

 

Patheon Puerto Rico, Inc.