Nateglinide tablet, coated

Ingredients and appearance - Product information

Nateglinide tablet, coated- Nateglinide

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0615-7585
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nateglinide ( UNII: 41X3PWK4O2)( Nateglinide - UNII: 41X3PWK4O2 ) 60 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Povidone k12 ( UNII: 333AG72FWJ)
Starch, corn ( UNII: O8232NY3SJ)
Ferric oxide red ( UNII: 1K09F3G675)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Polyvinyl alcohol ( UNII: 532B59J990)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color PINK Imprint Code P;984
Score 1 Shape ROUND
Size 1 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077463 USA

Nateglinide tablet, coated- Nateglinide

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0615-7586
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nateglinide ( UNII: 41X3PWK4O2)( Nateglinide - UNII: 41X3PWK4O2 ) 120 mgin 1

Inactive Ingredients

Ingredient Name Code
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Ferric oxide yellow ( UNII: EX438O2MRT)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Povidone k12 ( UNII: 333AG72FWJ)
Starch, corn ( UNII: O8232NY3SJ)

Product Characteristics

Color ORANGE Imprint Code P;985
Score 1 Shape OVAL
Size 6 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077463 USA

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs( 050052943)

Establishment

Name ID/FEI Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL( 0615-7585, 0615-7586), REPACK( 0615-7585, 0615-7586)