NDC 50383-912

Bimatoprost

Bimatoprost

Bimatoprost is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Bimatoprost.

Product ID50383-912_117fe874-a61a-4bcd-8b17-1a7e49e89174
NDC50383-912
Product TypeHuman Prescription Drug
Proprietary NameBimatoprost
Generic NameBimatoprost
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2018-10-10
Marketing CategoryANDA / ANDA
Application NumberANDA203051
Labeler NameHi-Tech Pharmacal Co., Inc.
Substance NameBIMATOPROST
Active Ingredient Strength3 ug/mL
Pharm ClassesProstaglandin Analog [EPC],Prostaglandins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50383-912-03

1 BOTTLE in 1 KIT (50383-912-03) > 3 mL in 1 BOTTLE
Marketing Start Date2018-09-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-912-03 [50383091203]

Bimatoprost SOLUTION
Marketing CategoryANDA
Application NumberANDA203051
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-10

Drug Details

Active Ingredients

IngredientStrength
BIMATOPROST3 ug/mL

OpenFDA Data

SPL SET ID:2c997c76-fd01-479a-a005-dbdb375560a4
Manufacturer
UNII
PHarm Class EPC
  • Prostaglandin Analog [EPC]
  • NUI Code
  • N0000175454
  • N0000007706
  • Pharmacological Class

    • Prostaglandin Analog [EPC]
    • Prostaglandins [Chemical/Ingredient]
    • Prostaglandins [CS]
    • Prostaglandin Analog [EPC]
    • Prostaglandins [CS]

    NDC Crossover Matching brand name "Bimatoprost" or generic name "Bimatoprost"

    NDCBrand NameGeneric Name
    0781-6206BimatoprostBimatoprost
    42571-128BIMATOPROSTBIMATOPROST
    50383-908BimatoprostBimatoprost
    50383-912BimatoprostBimatoprost
    57297-429bimatoprostbimatoprost
    60505-0583BimatoprostBimatoprost
    62332-507BimatoprostBimatoprost
    62332-511bimatoprostbimatoprost
    65862-802BimatoprostBimatoprost
    68083-295BimatoprostBimatoprost
    68083-296BimatoprostBimatoprost
    68083-439BimatoprostBimatoprost
    68180-429bimatoprostbimatoprost
    70069-403BimatoprostBimatoprost
    70069-401BimatoprostBimatoprost
    70069-402BimatoprostBimatoprost
    72266-140BimatoprostBimatoprost
    72266-139BimatoprostBimatoprost
    0023-9652DURYSTAbimatoprost
    0023-3616LATISSEbimatoprost
    0023-3205LUMIGANbimatoprost

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