NDC Code(s) : 49349-749-01
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ipratropium BromideIpratropium Bromide SPRAY, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-749
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IPRATROPIUM BROMIDE ANHYDROUS(UNII: VJV4X1P2Z1)
(IPRATROPIUM - UNII:GR88G0I6UL) 		IPRATROPIUM BROMIDE ANHYDROUS42 ug
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
EDETATE DISODIUM(UNII: 7FLD91C86K)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-749-011 in 1 CARTON Type 0: Not a Combination Product18/07/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076103 07/18/2012 05/28/2015

PRINCIPAL DISPLAY PANEL

DRUG: Ipratropium Bromide


GENERIC: Ipratropium Bromide


DOSAGE: SPRAY, METERED


ADMINSTRATION: NASAL


NDC: 49349-749-01


ACTIVE INGREDIENT(S):

  • IPRATROPIUM BROMIDE 42ug in 1


INACTIVE INGREDIENT(S):

  • BENZALKONIUM CHLORIDE
  • SODIUM CHLORIDE
  • WATER
  • EDETATE DISODIUM
  • HYDROCHLORIC ACID
  • SODIUM HYDROXIDE


PACKAGING: 1 in 1 CARTON



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