NDC Code(s) : 13925-540-12
Packager : Seton Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Memantine HydrochlorideMemantine Hydrochloride Oral SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13925-540
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE(UNII: JY0WD0UA60)
(MEMANTINE - UNII:W8O17SJF3T) 		MEMANTINE HYDROCHLORIDE2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SORBITOL SOLUTION 70%(UNII: 8KW3E207O2)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
GLYCERIN(UNII: PDC6A3C0OX)
PEPPERMINT(UNII: V95R5KMY2B)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13925-540-12360 mL in 1 BOTTLE Type 0: Not a Combination Product19/05/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210319 08/31/2020

LABELER - Seton Pharmaceuticals(828898002)

REGISTRANT - Seton Pharmaceuticals(828898002)

Establishment
Name Address ID/FEI Business Operations
Medley Pharmaceuticals Limited 677602480 manufacture(13925-540)

PRINCIPAL DISPLAY PANEL

​NDC ​13925-​540​-12

​Memantine Hydrochloride Oral Solution

2 mg/mL

Rx only

12 fl oz (360 mL)

Seton Pharmaceuticals

Each mL contains 2 mg memantine hydrochloride.

Verify tamper evident seal is intact on the bottle.

Do not use if the foil seal is broken or missing.

Keep out of reach of children.

Dispense in a tightly closed container as described in the USP.

Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Usual Dosage: See package insert for dosing and full prescribing information.

Manufactured by: Medley Pharmaceuticals Ltd.

Plot No. 18 & 19, Zari Causeway Road, Kachigam, Daman 396210, INDIA.

Manufactured for: Seton Pharmaceuticals

Wall. NJ 07719

1 (800) 510-3401

Issued : 02/21            Code No.: DD/DRUGS/DD/220

Label