NDC 0378-7055

Bepotastine Besilate

Bepotastine Besilate

Bepotastine Besilate is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Bepotastine Besilate.

Product ID0378-7055_75178670-aa57-45f9-94d5-efcf8305e683
NDC0378-7055
Product TypeHuman Prescription Drug
Proprietary NameBepotastine Besilate
Generic NameBepotastine Besilate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-03-18
Marketing CategoryANDA /
Application NumberANDA206220
Labeler NameMylan Pharmaceuticals Inc.
Substance NameBEPOTASTINE BESILATE
Active Ingredient Strength15 mg/mL
Pharm ClassesHistamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-7055-35

1 BOTTLE, DROPPER in 1 CARTON (0378-7055-35) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2021-05-28
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Bepotastine Besilate" or generic name "Bepotastine Besilate"

NDCBrand NameGeneric Name
0378-7055Bepotastine BesilateBepotastine Besilate
24208-630Bepotastine Besilatebepotastine besilate
60505-6111Bepotastine BesilateBepotastine Besilate
82260-630Bepotastine Besilatebepotastine besilate
24208-629Beprevebepotastine besilate

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