NDC 50090-3104

Atropine

Atropine Sulfate

Atropine is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Atropine Sulfate.

Product ID50090-3104_62d00ebd-2a13-4e80-b64f-87f037611f89
NDC50090-3104
Product TypeHuman Prescription Drug
Proprietary NameAtropine
Generic NameAtropine Sulfate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-07-18
Marketing CategoryNDA / NDA
Application NumberNDA206289
Labeler NameA-S Medication Solutions
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 Through2019-12-31

Packaging

NDC 50090-3104-0

1 BOTTLE, DROPPER in 1 CARTON (50090-3104-0) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2017-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-3104-0 [50090310400]

Atropine SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA206289
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-01-22
Marketing End Date2020-01-22

Drug Details

Active Ingredients

IngredientStrength
ATROPINE SULFATE10 mg/mL

OpenFDA Data

SPL SET ID:41100cf2-143b-4a1b-a8b9-867a99f3d7f7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1190655

    • 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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