NDC 0065-0303

Isopto Atropine

Atropine Sulfate

Isopto Atropine is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Atropine Sulfate.

Product ID0065-0303_403bf4bb-615b-4e29-8dde-5b0a01dbf256
NDC0065-0303
Product TypeHuman Prescription Drug
Proprietary NameIsopto Atropine
Generic NameAtropine Sulfate
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2016-12-09
Marketing CategoryNDA / NDA
Application NumberNDA208151
Labeler NameAlcon Laboratories, Inc.
Substance NameATROPINE SULFATE
Active Ingredient Strength10 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0065-0303-15

1 BOTTLE, DROPPER in 1 CARTON (0065-0303-15) > 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date2016-12-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-0303-55 [00065030355]

Isopto Atropine SOLUTION
Marketing CategoryNDA
Application NumberNDA208151
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-09

NDC 0065-0303-15 [00065030315]

Isopto Atropine SOLUTION
Marketing CategoryNDA
Application NumberNDA208151
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-09

Drug Details

Active Ingredients

IngredientStrength
ATROPINE SULFATE10 mg/mL

OpenFDA Data

SPL SET ID:20491566-e6eb-8d4a-3083-77ea429f7bc4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1190655
  • 1190664

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]

    NDC Crossover Matching brand name "Isopto Atropine" or generic name "Atropine Sulfate"

    NDCBrand NameGeneric Name
    0065-0303Isopto Atropineatropine sulfate
    0065-0817atropine sulfateatropine sulfate
    0404-9819ATROPINE SULFATEatropine sulfate
    0404-9820Atropine SulfateAtropine Sulfate
    0404-9821Atropine SulfateAtropine Sulfate
    0404-9822Atropine SulfateAtropine Sulfate
    0404-9823Atropine SulfateAtropine Sulfate
    0404-9824Atropine SulfateAtropine Sulfate
    0409-1630Atropine SulfateATROPINE SULFATE
    0409-4910ATROPINE SULFATEATROPINE SULFATE
    0409-4911ATROPINE SULFATEATROPINE SULFATE
    0409-9630Atropine SulfateATROPINE SULFATE
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