Fosinopril Sodium (Page 6 of 6)

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count20mg
1567544-431-15
3067544-431-30
4567544-431-45
6067544-431-53
9067544-431-60
12067544-431-70
13567544-431-73
18067544-431-80
27067544-431-92
36067544-431-94
Count40mg
4543353-870-45

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20140716SC

PRINCIPAL DISPLAY PANEL — 20mg

NDC 67544-431 — Fosinopril NA 20mg — Rx Only

Bottle Label 20mg
(click image for full-size original)

FOSINOPRIL SODIUM fosinopril sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67544-431(NDC:76282-201)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSINOPRIL SODIUM (FOSINOPRILAT) FOSINOPRIL SODIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
LACTOSE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POVIDONE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code IG;201
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67544-431-15 15 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:67544-431-30 30 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:67544-431-45 45 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:67544-431-53 60 TABLET in 1 BOTTLE, PLASTIC None
5 NDC:67544-431-60 90 TABLET in 1 BOTTLE, PLASTIC None
6 NDC:67544-431-70 120 TABLET in 1 BOTTLE, PLASTIC None
7 NDC:67544-431-73 135 TABLET in 1 BOTTLE, PLASTIC None
8 NDC:67544-431-80 180 TABLET in 1 BOTTLE, PLASTIC None
9 NDC:67544-431-92 270 TABLET in 1 BOTTLE, PLASTIC None
10 NDC:67544-431-94 360 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077222 06/21/2005
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 Repack (67544-431)

Revised: 07/2014 Aphena Pharma Solutions — Tennessee, LLC

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