CITALOPRAM HYDROBROMIDE (Page 8 of 8)

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. 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:

Count20 mg
1571610-092-15
3071610-092-30
4571610-092-45
9071610-092-60

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
20180716JH

PRINCIPAL DISPLAY PANEL — 20 mg

NDC 71610-092 — Citalopram HBr 20 mg — Rx Only

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

CITALOPRAM HYDROBROMIDE citalopram tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-092(NDC:76282-629)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITALOPRAM HYDROBROMIDE (CITALOPRAM) CITALOPRAM 20 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE RED
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND (bi-convex) Size 7mm
Flavor Imprint Code IG;207
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-092-15 15 TABLET in 1 BOTTLE None
2 NDC:71610-092-30 30 TABLET in 1 BOTTLE None
3 NDC:71610-092-45 45 TABLET in 1 BOTTLE None
4 NDC:71610-092-60 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077534 11/10/2017
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-092)

Revised: 07/2018 Aphena Pharma Solutions — Tennessee, LLC

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