NDC 76519-1161

OLOPATADINE HYDROCHLORIDE

Olopatadine Hydrochloride

OLOPATADINE HYDROCHLORIDE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Olopatadine Hydrochloride.

Product ID76519-1161_91466fe8-f0ce-084d-e053-2a95a90ae655
NDC76519-1161
Product TypeHuman Prescription Drug
Proprietary NameOLOPATADINE HYDROCHLORIDE
Generic NameOlopatadine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2018-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA206306
Labeler NameH.J. Harkins Company, Inc.
Substance NameOLOPATADINE HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesDecreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 76519-1161-0

5 mL in 1 BOTTLE (76519-1161-0)
Marketing Start Date2018-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1161-0 [76519116100]

OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA206306
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-31

Drug Details

Active Ingredients

IngredientStrength
OLOPATADINE HYDROCHLORIDE1.11 mg/mL

OpenFDA Data

SPL SET ID:91466fe8-f0cd-084d-e053-2a95a90ae655
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1111339
  • Pharmacological Class

    • Decreased Histamine Release [PE]
    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Inhibitor [EPC]
    • Decreased Histamine Release [PE]
    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Inhibitor [EPC]

    NDC Crossover Matching brand name "OLOPATADINE HYDROCHLORIDE" or generic name "Olopatadine Hydrochloride"

    NDCBrand NameGeneric Name
    0093-7684Olopatadine HydrochlorideOlopatadine Hydrochloride
    0363-0200OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    0363-8022OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    0378-8023Olopatadine HydrochlorideOlopatadine Hydrochloride
    68788-6317Olopatadine HydrochlorideOlopatadine Hydrochloride
    68788-7403Olopatadine HydrochlorideOlopatadine Hydrochloride
    68788-7301Olopatadine HydrochlorideOlopatadine Hydrochloride
    69097-275Olopatadine HydrochlorideOlopatadine Hydrochloride
    69097-276Olopatadine HydrochlorideOlopatadine Hydrochloride
    70069-007OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    45802-104olopatadine hydrochlorideolopatadine hydrochloride
    50090-3384Olopatadine HydrochlorideOlopatadine Hydrochloride
    50090-3566OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    60505-0586Olopatadine HydrochlorideOlopatadine Hydrochloride
    60505-0575Olopatadine HydrochlorideOlopatadine Hydrochloride
    60505-0845Olopatadine HydrochlorideOlopatadine Hydrochloride
    61314-272Olopatadine HydrochlorideOlopatadine Hydrochloride
    61314-320Olopatadine HydrochlorideOlopatadine Hydrochloride
    61314-271olopatadine hydrochlorideolopatadine hydrochloride
    62332-501OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    64679-363Olopatadine HydrochlorideOlopatadine Hydrochloride
    64980-517Olopatadine HydrochlorideOlopatadine Hydrochloride
    65862-757Olopatadine HydrochlorideOlopatadine Hydrochloride
    59651-066Olopatadine HydrochlorideOlopatadine Hydrochloride
    62332-502OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    68083-230Olopatadine HydrochlorideOlopatadine Hydrochloride
    51293-838olopatadine hydrochlorideolopatadine hydrochloride
    68071-5085OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    69367-233Olopatadine HydrochlorideOlopatadine Hydrochloride
    71205-345OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    76519-1161OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    72189-053OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    65162-890Olopatadine HydrochlorideOlopatadine Hydrochloride
    79903-000OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    58602-009OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    58602-012OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    58602-013OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    46122-672OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    50383-943Olopatadine HydrochlorideOlopatadine Hydrochloride
    46122-671OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    72036-008OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    17478-105OlopatadineOlopatadine Hydrochloride
    17478-305OlopatadineOlopatadine Hydrochloride
    0065-0272PATADAYolopatadine hydrochloride
    0065-0816PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDE
    0065-8150PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDE
    0065-4274PATADAY TWICE A DAY RELIEFOLOPATADINE HYDROCHLORIDE
    0065-0332PATANASEolopatadine hydrochloride
    0078-0834PATANASEolopatadine hydrochloride
    0065-0271Patanololopatadine hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.