NDC 17478-716

Apraclonidine Ophthalmic

Apraclonidine Hydrochloride

Apraclonidine Ophthalmic is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Apraclonidine Hydrochloride.

Product ID17478-716_048c16f8-5c7c-40f0-955b-98d4c1392190
NDC17478-716
Product TypeHuman Prescription Drug
Proprietary NameApraclonidine Ophthalmic
Generic NameApraclonidine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2009-08-12
Marketing CategoryANDA / ANDA
Application NumberANDA077764
Labeler NameAkorn
Substance NameAPRACLONIDINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAdrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 17478-716-10

1 BOTTLE, DROPPER in 1 CARTON (17478-716-10) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2009-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-716-11 [17478071611]

Apraclonidine Ophthalmic SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-08-12

NDC 17478-716-10 [17478071610]

Apraclonidine Ophthalmic SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-08-12

Drug Details

Active Ingredients

IngredientStrength
APRACLONIDINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:dc7d3a9f-c0b9-411c-9c62-0a14f1718b00
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308345
    • UPC Code
  • 0317478716105

    • Pharmacological Class

    • Adrenergic alpha-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]
    • Adrenergic alpha-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]

    Medicade Reported Pricing

    17478071610 APRACLONIDINE HCL 0.5% DROPS

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Apraclonidine Ophthalmic" or generic name "Apraclonidine Hydrochloride"

    NDCBrand NameGeneric Name
    17478-716Apraclonidine OphthalmicApraclonidine Hydrochloride
    0065-0660IOPIDINEapraclonidine hydrochloride
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.