NDC Code(s) : 68083-295-01, 68083-296-01, 68083-439-01
Packager : Gland Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bimatoprost Bimatoprost SOLUTION/ DROPS
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:68083-295
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BIMATOPROST(UNII: QXS94885MZ)
(BIMATOPROST - UNII:QXS94885MZ) 		BIMATOPROST0.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)0.05 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE(UNII: 70WT22SF4B)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68083-295-011 in 1 CARTON 02/12/2019
12.5 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210126 02/12/2019
Bimatoprost Bimatoprost SOLUTION/ DROPS
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:68083-296
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BIMATOPROST(UNII: QXS94885MZ)
(BIMATOPROST - UNII:QXS94885MZ) 		BIMATOPROST0.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)0.05 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE(UNII: 70WT22SF4B)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68083-296-011 in 1 CARTON 02/12/2019
15 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210126 02/12/2019
Bimatoprost Bimatoprost SOLUTION/ DROPS
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:68083-439
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BIMATOPROST(UNII: QXS94885MZ)
(BIMATOPROST - UNII:QXS94885MZ) 		BIMATOPROST0.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)0.05 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE(UNII: 70WT22SF4B)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68083-439-011 in 1 CARTON 08/12/2020
17.5 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210126 08/12/2020

LABELER - Gland Pharma Limited(918601238)

Establishment
Name Address ID/FEI Business Operations
GLAND PHARMA LIMITED 918601238 ANALYSIS(68083-295, 68083-296, 68083-439), MANUFACTURE(68083-295, 68083-296, 68083-439), PACK(68083-295, 68083-296, 68083-439)

PRINCIPAL DISPLAY PANEL

Bottle Label - 2.5 mL:

NDC 68083-295-01               2.5 mL

Bimatoprost

Ophthalmic

Solution

0.03%
For Use in the Eyes Only

Rx Only                  sterile
bima-spl-2-5-ml-bottle-label
Carton Label - 2.5 mL:

NDC 68083-295-01               2.5 mL

Bimatoprost

Ophthalmic

Solution

0.03%
For Use in the

Eyes Only

Rx Only              sterile

bima-spl-2-5-ml-bottle-label

Bottle Label - 5 mL  :

NDC 68083-296-01               5 mL

Bimatoprost

Ophthalmic

Solution

0.03%
For Use in the Eyes Only

Rx Only                  sterile

bima-spl-2-5-ml-bottle-label

Carton Label - 5 mL:

NDC 68083-296-01               5 mL

Bimatoprost

Ophthalmic

Solution

0.03%
For Use in the

Eyes Only

Rx Only                   sterile

bima-spl-2-5-ml-bottle-label

Bottle Label - 7.5 mL:

NDC 68083-439-01               7.5 mL

Bimatoprost

Ophthalmic

Solution

0.03%
For Use in the Eyes Only

Rx Only                  Sterile

bima-spl-2-5-ml-bottle-label

Carton Label - 7.5 mL:

NDC 68083-439-01               7.5 mL

Bimatoprost

Ophthalmic

Solution

0.03%
For Use in the

Eyes Only

Rx Only                   sterile

bima-spl-2-5-ml-bottle-label