NDC Code(s) : 52125-248-08
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Atropine SulfateATROPINE SULFATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-248(NDC:0409-1630)
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATROPINE SULFATE(UNII: 03J5ZE7KA5)
(ATROPINE - UNII:7C0697DR9I) 		ATROPINE SULFATE0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SULFURIC ACID(UNII: O40UQP6WCF)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-248-0810 mL in 1 SYRINGE, PLASTIC Type 0: Not a Combination Product31/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021146 10/31/2013 01/20/2017

PRINCIPAL DISPLAY PANEL

DRUG: Atropine Sulfate


GENERIC: ATROPINE SULFATE


DOSAGE: INJECTION, SOLUTION


ADMINSTRATION: INTRAMUSCULAR


NDC: 52125-248-08


ACTIVE INGREDIENT(S):

  • ATROPINE SULFATE 0.1mg in 1mL


INACTIVE INGREDIENT(S):

  • SODIUM CHLORIDE
  • SULFURIC ACID
  • SODIUM HYDROXIDE
  • WATER


PACKAGING: 10 mL in 1 SYRINGE, PLASTIC




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