Patient Information ⮝
Advise patients not to touch the dropper tip to any surface as this may contaminate the solution.
Advise patients that drops will sting upon instillation and advise patients that they will experience sensitivity to light and blurred vision which may last for a couple of weeks.
AKORN
Manufactured by:Akorn, Inc.
Lake forest, IL 60045AS00N Rev. 10/16
Principal Display Panel Text For Container Label: ⮝
NDC 17478-215-02
Atropine Sulfate
Ophthalmic
Solution, USP
1%
FOR TOPICAL
APPLICATION TO THE EYE
Sterile
Rx only 2 mL
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Principal Display Panel Text For Carton Label: ⮝
NDC 17478-215-02
Atropine
Sulfate
Ophthalmic
Solution, USP
1%
FOR TOPICAL APPLICATION
TO THE EYE
Sterile
2 mL
Rx only Akorn Logo
ATROPINE
atropine sulfate solution/ drops
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-215 Route of Administration OPHTHALMIC
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Atropine Sulfate(UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I) Atropine Sulfate 10 mg in 1 mL
Inactive Ingredients Ingredient Name Strength Benzalkonium Chloride(UNII: F5UM2KM3W7) Sodium Phosphate, Dibasic(UNII: GR686LBA74) Edetate Disodium(UNII: 7FLD91C86K) Hypromellose 2910 (4000 MPA.S)(UNII: RN3152OP35) Sodium Phosphate, Monobasic(UNII: 3980JIH2SW) Hydrochloric Acid(UNII: QTT17582CB) Sodium Hydroxide(UNII: 55X04QC32I) Water(UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17478-215-02 1 in 1 CARTON 07/18/2014 1 2 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:17478-215-05 1 in 1 CARTON 07/18/2014 2 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 3 NDC:17478-215-15 1 in 1 CARTON 07/18/2014 3 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206289 07/18/2014
Labeler -Akorn, Inc. (062649876)
Establishment Name Address ID/FEI Business Operations Akorn, Inc 063434679 PACK(17478-215) , LABEL(17478-215)
Establishment Name Address ID/FEI Business Operations Akorn, Inc. 155135783 MANUFACTURE(17478-215) , ANALYSIS(17478-215) , STERILIZE(17478-215)
Revised: 11/2017document Id: ⮝
b9d7003c-5a44-45d1-bfdd-620fe17ecf9bSet id: f7b40bf1-3063-4849-a5a0-0ac5d0d1e72aVersion: 8Effective Time: 20171120Akorn, Inc.