NDC 13985-606

Atropine

Atropine Sulfate

Atropine is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Mwi. The primary component is Atropine Sulfate.

Product ID13985-606_7d53942b-38a5-4316-9180-2fad2eb727db
NDC13985-606
Product TypeHuman Prescription Drug
Proprietary NameAtropine
Generic NameAtropine Sulfate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2015-03-23
Marketing CategoryNDA / NDA
Application NumberNDA206289
Labeler NameMWI
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 13985-606-05

1 BOTTLE, DROPPER in 1 CARTON (13985-606-05) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2015-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13985-606-05 [13985060605]

Atropine SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA206289
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-23

Drug Details

Active Ingredients

IngredientStrength
ATROPINE SULFATE10 mg/mL

OpenFDA Data

SPL SET ID:590a4e7b-565f-415f-a8e4-499a382c9a3b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1190655
    • UPC Code
  • 0313985012556

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    13985-606AtropineAtropine
    17478-215AtropineAtropine
    50090-3104AtropineAtropine
    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
    0065-0303Isopto Atropineatropine sulfate
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