NDC 68083-230

Olopatadine Hydrochloride

Olopatadine Hydrochloride Ophthalmic Solution Usp, 0.1%

Olopatadine Hydrochloride is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Olopatadine Hydrochloride.

Product ID68083-230_2515239c-e23c-4d40-88ce-49ffae0524f4
NDC68083-230
Product TypeHuman Prescription Drug
Proprietary NameOlopatadine Hydrochloride
Generic NameOlopatadine Hydrochloride Ophthalmic Solution Usp, 0.1%
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2017-02-14
Marketing CategoryANDA / ANDA
Application NumberANDA209619
Labeler NameGland Pharma Limited
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 68083-230-01

1 BOTTLE, PLASTIC in 1 CARTON (68083-230-01) > 5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2017-02-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-230-01 [68083023001]

Olopatadine Hydrochloride SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA209619
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-14

Drug Details

Active Ingredients

IngredientStrength
OLOPATADINE HYDROCHLORIDE1 mg/mL

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 Ophthalmic Solution Usp, 0.1%"

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.