Bimatoprost (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2.5 mL Container Label

2.5 mL Container Label
(click image for full-size original)

2.5 mL Monocarton Label

2.5 mL Carton Label
(click image for full-size original)

5 mL Container Label

5 mL container label
(click image for full-size original)

5 mL Monocarton Label

5 ml monocarton label
(click image for full-size original)

7.5 mL Container Label

7.5 mL container label
(click image for full-size original)

7.5 mL Monocarton Label

7.5 mL monocarton label
(click image for full-size original)
BIMATOPROST
bimatoprost solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-401
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BIMATOPROST (BIMATOPROST) BIMATOPROST 0.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Product Characteristics
Color WHITE (Clear, colorless solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70069-401-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 2.5 mL in 1 BOTTLE This package is contained within the CARTON (70069-401-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207601 06/19/2019
BIMATOPROST
bimatoprost solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-402
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BIMATOPROST (BIMATOPROST) BIMATOPROST 0.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Product Characteristics
Color WHITE (Clear, colorless solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70069-402-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 5 mL in 1 BOTTLE This package is contained within the CARTON (70069-402-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207601 06/19/2019
BIMATOPROST
bimatoprost solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-403
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BIMATOPROST (BIMATOPROST) BIMATOPROST 0.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Product Characteristics
Color WHITE (Clear, colorless solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70069-403-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 7.5 mL in 1 BOTTLE This package is contained within the CARTON (70069-403-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207601 06/19/2019
Labeler — Somerset Therapeutics, LLC (079947873)
Registrant — Somerset Therapeutics, LLC (079947873)
Establishment
Name Address ID/FEI Operations
Somerset Therapeutics Limited 677236695 ANALYSIS (70069-401), ANALYSIS (70069-402), ANALYSIS (70069-403), LABEL (70069-401), LABEL (70069-402), LABEL (70069-403), MANUFACTURE (70069-401), MANUFACTURE (70069-402), MANUFACTURE (70069-403), PACK (70069-401), PACK (70069-402), PACK (70069-403)

Revised: 03/2022 Somerset Therapeutics, LLC

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