Drug Labeling and Warnings

Drug Details [pdf]

PERINDOPRIL ERBUMINE - perindopril erbumine tablet 
Aurobindo Pharma Limited

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Perindopril Erbumine Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Bulk Tablet Label


12000 Tablets

Batch      :

Mfg         :

Expiry      :

To be repacked within six months from the date of manufacturing

NDC: 65862-286-53

BULK SHIPMENT
PLEASE HANDLE CAREFULLY

Rx only

Perindopril Erbumine Tablets 2 mg

Each tablet contains: Perindopril erbumine 2 mg.

CAUTION: FOR REPACKAGING ONLY

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to
15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Bulk Tablet Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg Bulk Tablet Label



10000 Tablets  
Batch      :

Mfg         :

Expiry      :

To be repacked within six months from the date of manufacturing

NDC: 65862-287-19

BULK SHIPMENT
PLEASE HANDLE CAREFULLY
 
Rx only

Perindopril Erbumine Tablets 4 mg
Each tablet contains: Perindopril erbumine 4 mg.

CAUTION: FOR REPACKAGING ONLY

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to
15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

Manufactured by:
Aurobindo Pharma Limited


Hyderabad-500 072, India



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg Bulk Tablet Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 mg Bulk Tablet Label


5000 Tablets

Batch      :

Mfg         :

Expiry      :

To be repacked within six months from the date of manufacturing

NDC: 65862-288-59

BULK SHIPMENT
PLEASE HANDLE CAREFULLY

Rx only

Perindopril Erbumine Tablets 8 mg

Each tablet contains: Perindopril erbumine 8 mg.

CAUTION: FOR REPACKAGING ONLY

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to
15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 mg Bulk Tablet Label
PERINDOPRIL ERBUMINE 
perindopril erbumine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65862-286
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K) PERINDOPRIL ERBUMINE2 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITE (White to Off-white) Score2 pieces
ShapeROUND (Biconvex) Size5mm
FlavorImprint Code D;5;7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65862-286-5312000 in 1 BAG; Type 0: Not a Combination Product11/10/200910/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07907011/10/200910/28/2019
PERINDOPRIL ERBUMINE 
perindopril erbumine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65862-287
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K) PERINDOPRIL ERBUMINE4 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITE (White to Off-white) Score2 pieces
ShapeCAPSULESize8mm
FlavorImprint Code D;5;8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65862-287-1910000 in 1 BAG; Type 0: Not a Combination Product11/10/200910/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07907011/10/200910/28/2019
PERINDOPRIL ERBUMINE 
perindopril erbumine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65862-288
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K) PERINDOPRIL ERBUMINE8 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITE (White to Off-white) Score2 pieces
ShapeROUND (Biconvex) Size8mm
FlavorImprint Code D;5;9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65862-288-595000 in 1 BAG; Type 0: Not a Combination Product11/10/200910/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07907011/10/200910/28/2019
Labeler - Aurobindo Pharma Limited (650082092)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(65862-286, 65862-287, 65862-288) , MANUFACTURE(65862-286, 65862-287, 65862-288)

Revised: 9/2019
Document Id: 9565958f-9380-47c7-be22-8a05ede8c9f0
Set id: d9033965-7cf5-41ef-9efa-d2eec745b43d
Version: 3
Effective Time: 20190913