Levalbuterol Hydrochloride (Page 7 of 7)


2
Potency expressed as levalbuterol

PRINCIPAL DISPLAY PANEL — 0.63 mg/3 mL Vial Carton

NDC 76204-002-24

Levalbuterol HCl Inhalation Solution

0.63 mg/3 mL *

*Potency expressed as levalbuterol

For Oral Inhalation Only. Sterile Unit-Dose Vial

0.63 mg

Rx only

24 x 3 mL Sterile Unit-Dose Vials

PRINCIPAL DISPLAY PANEL -- 0.63 mg/3 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1.25 mg/3 mL Vial Carton

NDC 76204-003-24

Levalbuterol HCl Inhalation Solution

1.25 mg/3 mL *

*Potency expressed as levalbuterol

For Oral Inhalation Only. Sterile Unit-Dose Vial

1.25 mg

Rx only

24 x 3 mL Sterile Unit-Dose Vials

PRINCIPAL DISPLAY PANEL -- 1.25 mg/3 mL Vial Carton
(click image for full-size original)
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76204-002
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levalbuterol Hydrochloride (Levalbuterol) Levalbuterol 0.63 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride
Sulfuric Acid
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76204-002-24 2 POUCH in 1 CARTON contains a POUCH
1 12 AMPULE in 1 POUCH This package is contained within the CARTON (76204-002-24) and contains a AMPULE
1 3 mL in 1 AMPULE This package is contained within a POUCH and a CARTON (76204-002-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020837 12/01/2012
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76204-003
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levalbuterol Hydrochloride (Levalbuterol) Levalbuterol 1.25 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride
Sulfuric Acid
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76204-003-24 2 POUCH in 1 CARTON contains a POUCH
1 12 AMPULE in 1 POUCH This package is contained within the CARTON (76204-003-24) and contains a AMPULE
1 3 mL in 1 AMPULE This package is contained within a POUCH and a CARTON (76204-003-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020837 12/01/2012
Labeler — Ritedose Pharmaceuticals, LLC (968062294)

Revised: 12/2012 Ritedose Pharmaceuticals, LLC

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 © 2024. All Rights Reserved.