NDC Code(s) : 49349-745-01
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PROAIRHFA albuterol sulfate AEROSOL, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-745(NDC:59310-579)
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
ALCOHOL(UNII: 3K9958V90M)
NORFLURANE(UNII: DH9E53K1Y8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-745-011 in 1 CONTAINER Type 0: Not a Combination Product18/07/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021457 07/18/2012 04/02/2014

PRINCIPAL DISPLAY PANEL

DRUG: PROAIRHFA HFA


GENERIC: albuterol sulfate


DOSAGE: AEROSOL, METERED


ADMINSTRATION: RESPIRATORY (INHALATION)


NDC: 49349-745-01


ACTIVE INGREDIENT(S):

  • ALBUTEROL SULFATE 90ug in 1


INACTIVE INGREDIENT(S):

  • ALCOHOL
  • NORFLURANE


PACKAGING: 1 in 1 CONTAINER



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