NDC Code(s) : 68071-3484-6, 68071-3484-3
Packager : NuCare Pharmaceuticals,Inc.w

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FLUOXETINEFLUOXETINE CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3484(NDC:23155-029)
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)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color yellow (opaque yellow body), green (opaque green cap) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code HP;29
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68071-3484-660 in 1 BOTTLE Type 0: Not a Combination Product21/08/2023
2NDC:68071-3484-330 in 1 BOTTLE Type 0: Not a Combination Product21/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201336 08/08/2021

LABELER - NuCare Pharmaceuticals,Inc.w(010632300)

Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 repack(68071-3484)

PRINCIPAL DISPLAY PANEL

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