NDC Code(s) : 63187-073-30, 63187-073-60, 63187-073-90, 63187-277-30, 63187-277-60, 63187-277-90
Packager : Proficient Rx LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RamiprilRamipril CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-073(NDC:68180-590)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAMIPRIL(UNII: L35JN3I7SJ)
(RAMIPRILAT - UNII:6N5U4QFC3G) 		RAMIPRIL5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MEGLUMINE(UNII: 6HG8UB2MUY)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code LUPIN;RAMIPRIL;5;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-073-3030 in 1 BOTTLE Type 0: Not a Combination Product06/01/2014
2NDC:63187-073-6060 in 1 BOTTLE Type 0: Not a Combination Product06/01/2014
3NDC:63187-073-9090 in 1 BOTTLE Type 0: Not a Combination Product06/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077626 06/10/2008
RamiprilRamipril CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-277(NDC:68180-591)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAMIPRIL(UNII: L35JN3I7SJ)
(RAMIPRILAT - UNII:6N5U4QFC3G) 		RAMIPRIL10 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MEGLUMINE(UNII: 6HG8UB2MUY)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code LUPIN;RAMIPRIL;10;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-277-3030 in 1 BOTTLE Type 0: Not a Combination Product06/01/2014
2NDC:63187-277-6060 in 1 BOTTLE Type 0: Not a Combination Product06/01/2014
3NDC:63187-277-9090 in 1 BOTTLE Type 0: Not a Combination Product06/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077626 06/10/2008

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 RELABEL(63187-073, 63187-277), REPACK(63187-073, 63187-277)

PRINCIPAL DISPLAY PANEL

63187-073-30

PRINCIPAL DISPLAY PANEL

63187-277-30