NDC Code(s) : 71610-683-30, 71610-683-60, 71610-699-30, 71610-699-53, 71610-699-60, 71610-699-70, 71610-699-80, 71610-699-92
Packager : Aphena Pharma Solutions - Tennessee, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FluoxetineFluoxetine Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-683(NDC:77771-113)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE(UNII: I9W7N6B1KJ)
(FLUOXETINE - UNII:01K63SUP8D) 		FLUOXETINE10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color blue (Opaque Light Blue), orange (Opaque Light Orange) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code SG;113
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71610-683-3030 in 1 BOTTLE Type 0: Not a Combination Product02/09/2023
2NDC:71610-683-6090 in 1 BOTTLE Type 0: Not a Combination Product30/12/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204597 10/24/2022
FluoxetineFluoxetine Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-699(NDC:77771-114)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE(UNII: I9W7N6B1KJ)
(FLUOXETINE - UNII:01K63SUP8D) 		FLUOXETINE20 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color blue (Opaque Light Blue), green (Opaque Light Green) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code SG;114
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71610-699-3030 in 1 BOTTLE Type 0: Not a Combination Product04/03/2023
2NDC:71610-699-5360 in 1 BOTTLE Type 0: Not a Combination Product04/03/2023
3NDC:71610-699-6090 in 1 BOTTLE Type 0: Not a Combination Product04/03/2023
4NDC:71610-699-70120 in 1 BOTTLE Type 0: Not a Combination Product04/03/2023
5NDC:71610-699-80180 in 1 BOTTLE Type 0: Not a Combination Product04/03/2023
6NDC:71610-699-92270 in 1 BOTTLE Type 0: Not a Combination Product04/03/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204597 10/24/2022

LABELER - Aphena Pharma Solutions - Tennessee, LLC(128385585)

Establishment
Name Address ID/FEI Business Operations
Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-683, 71610-699)

PRINCIPAL DISPLAY PANEL

NDC 71610-683 - Fluoxetine, USP 10 mg Capsules - Rx Only
Bottle Label 10 mg

PRINCIPAL DISPLAY PANEL

NDC 71610-699 - Fluoxetine, USP 20mg Capsules - Rx Only
Bottle Label 20 mg