Baclofen (Intrathecal) (Page 4 of 4)

HOW SUPPLIED

Baclofen injection (intrathecal) is a clear, colorless, sterile, pyrogen-free, isotonic solution consisting of the active ingredient, Baclofen USP, and the excipients Sodium Chloride USP and Water for Injection USP in single-dose clear glass vials.

Baclofen Injection (Intrathecal) is packaged in single-dose vials containing 10 mg/20 mL (500 mcg/mL) or 40 mg/20 mL (2000 mcg/mL) supplied as follows:

One vial containing 10 mg/20 mL (500 mcg/mL) (NDC 70511-122-10).

One vial containing 40 mg/20 mL (2000 mcg/mL) (NDC 70511-124-10).

Storage:

Does not require refrigeration.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)[See USP Controlled Room Temperature]
Do not freeze.
Do not heat sterilize

Manufactured for:
MAIA Pharmaceuticals, Inc.
707 State Road
Suite 104, Princeton, NJ 08540

Made in India

Revised: 7/2019

PRINCIPAL DISPLAY PANEL — Baclofen Injection (Intrathecal) 10 mg/20 mL (500 mcg/mL)

NDC 70511-122 -10

Baclofen Injection (Intrathecal)

10 mg/20 mL

(500 mcg/mL)

Sterile Solution for Intrathecal Injection

Rx Only

Vial NDC 70511-122-20
(click image for full-size original)

NDC 70511-​122 ​-20

Baclofen Injection (Intrathecal)

10 mg/20 mL

(500 mcg/mL)

Sterile solution

for Intrathetical

injection only

Contain one 20 mL Single-Dose Vial

Carton NDC 70511-122-20
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Baclofen Injection (Intrathecal) 40 mg/20 mL (2000 mcg/mL)

NDC 70511-124-10

Baclofen Injection (Intrathecal)

40 mg/20 mL

(2000 mcg/mL)

Sterile Solution

for Intrathecal Injection

Rx Only

Container Label NDC 70511-124-10
(click image for full-size original)

NDC 70511-124 -20

Baclofen Injection (Intrathecal)

40 mg/20 mL

(2,000 mcg/mL)

Sterile solution

for Intrthecal

injection only

Contains one 20 mL Single-Dose Vial

Carton Label NDC 70511-124-10
(click image for full-size original)
BACLOFEN (INTRATHECAL)
baclofen injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70511-122
Route of Administration INTRATHECAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 500 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70511-122-10 1 VIAL in 1 CARTON contains a VIAL
1 20 mL in 1 VIAL This package is contained within the CARTON (70511-122-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210048 09/25/2019
BACLOFEN (INTRATHECAL)
baclofen injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70511-124
Route of Administration INTRATHECAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 2000 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg in 1 mL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70511-124-10 1 VIAL in 1 CARTON contains a VIAL
1 20 mL in 1 VIAL This package is contained within the CARTON (70511-124-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210048 09/25/2019
Labeler — MAlA Pharmaceuticals, Inc. (079211845)
Registrant — MAlA Pharmaceuticals, Inc. (079211845)
Establishment
Name Address ID/FEI Operations
Gland Pharma Limited 918601238 manufacture (70511-122), manufacture (70511-124)

Revised: 03/2017 MAlA Pharmaceuticals, Inc.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.