Memantine Hydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Memantine Hydrochloride Tablets, USP 5 mg Container Label 60’s Count

memantinetabs5mg60scount
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Memantine Hydrochloride Tablets, USP 10 mg Container Label 60’s Count

memantinetabs10mg60scount
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MEMANTINE HYDROCHLORIDE memantine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-807
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
POVIDONE K30
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color brown (Tan) Score no score
Shape CAPSULE (biconvex) Size 10mm
Flavor Imprint Code J;47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-807-60 60 TABLET in 1 BOTTLE None
2 NDC:31722-807-02 200 TABLET in 1 BOTTLE None
3 NDC:31722-807-32 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (31722-807-32)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204389 09/26/2022
MEMANTINE HYDROCHLORIDE memantine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-808
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
POVIDONE K30
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color gray Score no score
Shape CAPSULE (biconvex) Size 12mm
Flavor Imprint Code J;48
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-808-60 60 TABLET in 1 BOTTLE None
2 NDC:31722-808-02 200 TABLET in 1 BOTTLE None
3 NDC:31722-808-32 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (31722-808-32)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204389 09/26/2022
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Annora Pharma Private Limited 650980746 manufacture (31722-807), manufacture (31722-808)

Revised: 10/2022 Camber Pharmaceuticals, Inc.

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