Methadone Hydrocloride (Page 6 of 6)

HOW SUPPLIED

Methadone Hydrochloride Oral Concentrate, USP 10 mg per mL is supplied as a red, cherry flavored liquid concentrate.

NDC 0527-1926-36 30 mL bottle in a carton with a calibrated dropper [graduations of 0.25 mL (2.5 mg), 0.5 mL (5 mg), 0.75 mL (7.5 mg), and 1 mL (10 mg) on the dropper].

NDC 0527-1926-39 1 Liter bottle

Dispense in tight containers, protected from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

10-1175
Rev. 06/21

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — Methadone Hydrochloride Oral Concentrate USP 30 mL Bottle Label

NDC 0527-1926 -36

Methadone
Hydrochloride
Oral Concentrate, USP

CII

10 mg per mL

Each mL contains:
10 mg Methadone Hydrochloride, USP.

Store at 20° to 25°C (68° to 77°F)
[see USP Controlled Room Temperature].

Rx Only 30 mL

Lannett

30 mL bottle label
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — Methadone Hydrochloride Oral Concentrate USP 1 Liter Bottle Label

NDC 0527-1926 -39

Methadone
Hydrochloride
Oral Concentrate, USP

CII

10 mg per mL

Rx Only 1 L (1000 mL)

Lannett

1 Liter bottle label
(click image for full-size original)
METHADONE HYDROCLORIDE methadone hydrochloride concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1926
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHADONE HYDROCHLORIDE (METHADONE) METHADONE HYDROCHLORIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
WATER
FD&C RED NO. 40
METHYLPARABEN
POLOXAMER 407
PROPYLENE GLYCOL
PROPYLPARABEN
TRISODIUM CITRATE DIHYDRATE
SUCROSE
Product Characteristics
Color red Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1926-36 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 30 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0527-1926-36)
2 NDC:0527-1926-39 1000 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212094 03/03/2021
Labeler — Lannett Company, Inc. (002277481)

Revised: 06/2021 Lannett Company, Inc.

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