Methadone Hydrochloride (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — 5 mL Cup Label

NDC 68094-031-59

PrecisionDose™

METHADONE Hydrochloride
Oral Solution USP 5 mg/5 mL

CII

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL -- 5 mL Cup Label
(click image for full-size original)
METHADONE HYDROCHLORIDE methadone hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68094-031(NDC:0054-3555)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methadone Hydrochloride (Methadone) Methadone Hydrochloride 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
alcohol
benzoic acid
anhydrous citric acid
FD&C Red No. 40
FD&C Yellow No. 6
Glycerin
Sorbitol
water
Product Characteristics
Color ORANGE Score
Shape Size
Flavor CITRUS Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68094-031-62 3 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (68094-031-62) and contains a CUP, UNIT-DOSE (68094-031-59)
1 NDC:68094-031-59 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-031-62)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087393 12/23/2020
Labeler — Precision Dose, Inc. (035886746)

Revised: 12/2023 Precision Dose, Inc.

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