Duloxetine Delayed-Release (Page 14 of 14)

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
50071610-739-74
600071610-739-16

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
20240115JK

PRINCIPAL DISPLAY PANEL — 20 mg

NDC 71610-739 — Duloxetine DR, USP 20 mg Capsules — Rx Only

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

DULOXETINE DELAYED-RELEASE duloxetine hydrochloride capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-739(NDC:51407-817)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE 20 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
TALC
TITANIUM DIOXIDE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
SODIUM LAURYL SULFATE
POLYSORBATE 80
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
SHELLAC
SUCROSE
STARCH, CORN
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow (Ochre) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code B;746
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-739-74 500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
2 NDC:71610-739-16 6000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203088 06/11/2014
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-739)

Revised: 01/2024 Aphena Pharma Solutions — Tennessee, LLC

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