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ATROPINE- atropine sulfate solution/ drops


  1. Patient Information
  2. Principal Display Panel Text For Container Label:
  3. Principal Display Panel Text For Carton Label:
  4. Revised: 11/2017document Id:

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 60045

AS00N 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

Principal Display Panel Text for Container Label

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

Principal Display Panel Text for Carton Label
ATROPINE
atropine sulfate solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-215
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atropine Sulfate(UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I)Atropine Sulfate10 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-215-021 in 1 CARTON07/18/2014
12 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:17478-215-051 in 1 CARTON07/18/2014
25 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC:17478-215-151 in 1 CARTON07/18/2014
315 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20628907/18/2014
Labeler -Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc063434679PACK(17478-215) , LABEL(17478-215)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc.155135783MANUFACTURE(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.



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