NDC Code(s) : 80425-0359-1
Packager : Advanced Rx Pharmacy of Tennessee, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Albuterol Sulfate albuterol sulfate AEROSOL, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80425-0359(NDC:66993-019)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE(UNII: 021SEF3731)
(ALBUTEROL - UNII:QF8SVZ843E) 		ALBUTEROL90 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE(UNII: DH9E53K1Y8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:80425-0359-11 in 1 CARTON 09/07/2023
1200 in 1 INHALER Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020983 09/07/2023

LABELER - Advanced Rx Pharmacy of Tennessee, LLC(117023142)

Establishment
Name Address ID/FEI Business Operations
Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack(80425-0359)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 80425-0359-01

Albuterol Sulfate HFA

Inhalation Aerosol

90 mcg per actuation

200 Metered Inhalations

For oral inhalation with Albuterol Sulfate HFA actuator only.

Discard when the counter reads 000.

Net Wt. 18 g

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA

Distributed by:

Advanced Rx Pharmacy of Tennessee, LLC

R xonly

Contents:A microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). Each actuation delivers 108 mcg of albuterol sulfate equivalent to 90 mcg albuterol base from the mouthpiece. See prescribing information for dosage information.

Important:Read accompanying directions carefully.

WARNING: Do not exceed the dose prescribed by your doctor.

If difficulty in breathing persists, get immediate medical help.

Contents Under Pressure:Do not puncture. Do not use or store near heat or open flame. Keep out of reach of children.

Shake the inhaler well before each spray.

Store at room temperature between 68 oF and 77 oF (20 oC and 25 oC) with the mouthpiece down

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