NATEGLINIDE- nateglinide tablet, film coated 
Cadila Healthcare Limited

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NATEGLINIDE TABELTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1015-9 in bottle of 90 tablets

Nateglinide Tablets USP, 60 mg

Rx only

90 tablets

nateglinide tabs 60 mg

NDC 70771-1016-9 in bottle of 90 tablets

Nateglinide Tablets USP, 120 mg

Rx only

90 tablets

nateglinide tabs 120 mg
NATEGLINIDE 
nateglinide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NATEGLINIDE (UNII: 41X3PWK4O2) (NATEGLINIDE - UNII:41X3PWK4O2) NATEGLINIDE60 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code 721
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1015-330 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
2NDC:70771-1015-990 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
3NDC:70771-1015-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
4NDC:70771-1015-5500 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
5NDC:70771-1015-01000 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
6NDC:70771-1015-410 in 1 CARTON10/27/2016
6NDC:70771-1015-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20524810/27/2016
NATEGLINIDE 
nateglinide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NATEGLINIDE (UNII: 41X3PWK4O2) (NATEGLINIDE - UNII:41X3PWK4O2) NATEGLINIDE120 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGE (LIGHT ORANGE TO ORANGE) Scoreno score
ShapeOVAL (OVAL) Size18mm
FlavorImprint Code 722
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1016-330 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
2NDC:70771-1016-990 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
3NDC:70771-1016-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
4NDC:70771-1016-5500 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
5NDC:70771-1016-01000 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
6NDC:70771-1016-410 in 1 CARTON10/27/2016
6NDC:70771-1016-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20524810/27/2016
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1015, 70771-1016) , MANUFACTURE(70771-1015, 70771-1016)

Revised: 9/2020
Document Id: b39ccb81-50e7-4748-99c3-caa8e71c7fe6
Set id: a82817dd-f8c4-4172-ba86-63c2beef456a
Version: 6
Effective Time: 20200901
 
Cadila Healthcare Limited