NDC 68083-295

Bimatoprost

Bimatoprost

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

Product ID68083-295_12e9ccfe-e6ba-48d9-aaa2-baa8a8939fde
NDC68083-295
Product TypeHuman Prescription Drug
Proprietary NameBimatoprost
Generic NameBimatoprost
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-02-12
Marketing CategoryANDA / ANDA
Application NumberANDA210126
Labeler NameGland Pharma Limited
Substance NameBIMATOPROST
Active Ingredient Strength0 mg/mL
Pharm ClassesProstaglandin Analog [EPC],Prostaglandins [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68083-295-01

1 BOTTLE in 1 CARTON (68083-295-01) > 2.5 mL in 1 BOTTLE
Marketing Start Date2019-02-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-295-01 [68083029501]

Bimatoprost SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA210126
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-12

Drug Details

Active Ingredients

IngredientStrength
BIMATOPROST.3 mg/mL

OpenFDA Data

SPL SET ID:2a4b5b6b-fc47-40d2-8396-ff60511a4cd1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308739
  • 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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