NDC 50090-3489

Olopatadine

Olopatadine Hydrochloride

Olopatadine 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 Olopatadine Hydrochloride.

Product ID50090-3489_1a8dfd8c-6be5-4bc2-b8ff-2070e71d0c13
NDC50090-3489
Product TypeHuman Prescription Drug
Proprietary NameOlopatadine
Generic NameOlopatadine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2017-12-05
Marketing CategoryANDA / ANDA
Application NumberANDA204723
Labeler NameA-S Medication Solutions
Substance NameOLOPATADINE HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesDecreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50090-3489-0

1 BOTTLE, DROPPER in 1 CARTON (50090-3489-0) > 2.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2018-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-3489-0 [50090348900]

Olopatadine SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA204723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-18
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
OLOPATADINE HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:151fd692-a33d-4514-92a6-eb780a1adc97
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1111343
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    17478-105OlopatadineOlopatadine Hydrochloride
    17478-305OlopatadineOlopatadine Hydrochloride
    50090-3489OlopatadineOlopatadine
    50090-3552OlopatadineOlopatadine
    60429-957OlopatadineOlopatadine
    0093-7684Olopatadine HydrochlorideOlopatadine Hydrochloride
    0363-0200OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    0363-8022OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE
    0378-8023Olopatadine HydrochlorideOlopatadine 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
    0065-4273Pazeoolopatadine hydrochloride

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