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 Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-286
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K) PERINDOPRIL ERBUMINE 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape ROUND (Biconvex) Size 5mm
Flavor Imprint Code D;5;7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-286-53 12000 in 1 BAG; Type 0: Not a Combination Product 11/10/2009 10/28/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079070 11/10/2009 10/28/2019
PERINDOPRIL ERBUMINE
perindopril erbumine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-287
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K) PERINDOPRIL ERBUMINE 4 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape CAPSULE Size 8mm
Flavor Imprint Code D;5;8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-287-19 10000 in 1 BAG; Type 0: Not a Combination Product 11/10/2009 10/28/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079070 11/10/2009 10/28/2019
PERINDOPRIL ERBUMINE
perindopril erbumine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-288
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K) PERINDOPRIL ERBUMINE 8 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code D;5;9
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-288-59 5000 in 1 BAG; Type 0: Not a Combination Product 11/10/2009 10/28/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079070 11/10/2009 10/28/2019
Labeler - Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917642 ANALYSIS(65862-286, 65862-287, 65862-288) , MANUFACTURE(65862-286, 65862-287, 65862-288)

Revised: 9/2019
Aurobindo Pharma Limited