Methylphenidate Hydrochloride (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71930-024-52
500 mL

CII

Methylphenidate Hydrochloride Oral Solution

5 mg per 5 mL
Rx Only

PHARMACIST: Dispense the enclosed Medication Guide to each patient. eywa pharma

5mg label
(click image for full-size original)

NDC 71930-025-52
500 mL

CII

Methylphenidate Hydrochloride Oral Solution

10 mg per 5 mL

Rx Only PHARMACIST: Dispense the enclosed Medication Guide to each patient.

eywa pharma

10 mg label
(click image for full-size original)
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71930-024
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
POLYETHYLENE GLYCOL
HYDROCHLORIC ACID
GRAPE
Product Characteristics
Color YELLOW (COLORLESS TO PALE YELLOW) Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71930-024-52 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210139 03/29/2019
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71930-025
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
POLYETHYLENE GLYCOL
HYDROCHLORIC ACID
GRAPE
Product Characteristics
Color YELLOW (COLORLESS TO PALE YELLOW) Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71930-025-52 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210139 03/29/2019
Labeler — Eywa Pharma Inc (080465609)
Establishment
Name Address ID/FEI Operations
Wes Pharma Inc 078706898 LABEL (71930-024), LABEL (71930-025), MANUFACTURE (71930-024), MANUFACTURE (71930-025), PACK (71930-024), PACK (71930-025)

Revised: 09/2021 Eywa Pharma Inc

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