NDC Code(s) : 69238-1745-8, 69238-1746-8, 69238-1747-8
Packager : Amneal Pharmaceuticals NY LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pilocarpine HydrochloridePilocarpine Hydrochloride SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1745
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PILOCARPINE HYDROCHLORIDE(UNII: 0WW6D218XJ)
(PILOCARPINE - UNII:01MI4Q9DI3) 		PILOCARPINE HYDROCHLORIDE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
BORIC ACID(UNII: R57ZHV85D4)
HYDROCHLORIC ACID(UNII: QTT17582CB)
HYPROMELLOSE 2910 (10000 MPA.S)(UNII: 0HO1H52958)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-1745-81 in 1 CARTON 23/09/2020
115 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 ANDA214193 09/23/2020
Pilocarpine HydrochloridePilocarpine Hydrochloride SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1746
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PILOCARPINE HYDROCHLORIDE(UNII: 0WW6D218XJ)
(PILOCARPINE - UNII:01MI4Q9DI3) 		PILOCARPINE HYDROCHLORIDE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
BORIC ACID(UNII: R57ZHV85D4)
HYDROCHLORIC ACID(UNII: QTT17582CB)
HYPROMELLOSE 2910 (10000 MPA.S)(UNII: 0HO1H52958)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-1746-81 in 1 CARTON 23/09/2020
115 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 ANDA214193 09/23/2020
Pilocarpine HydrochloridePilocarpine Hydrochloride SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1747
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PILOCARPINE HYDROCHLORIDE(UNII: 0WW6D218XJ)
(PILOCARPINE - UNII:01MI4Q9DI3) 		PILOCARPINE HYDROCHLORIDE40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
BORIC ACID(UNII: R57ZHV85D4)
HYDROCHLORIC ACID(UNII: QTT17582CB)
HYPROMELLOSE 2910 (10000 MPA.S)(UNII: 0HO1H52958)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-1747-81 in 1 CARTON 23/09/2020
115 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 ANDA214193 09/23/2020

LABELER - Amneal Pharmaceuticals NY LLC(123797875)

PRINCIPAL DISPLAY PANEL

NDC 69238-1745-8
Pilocarpine hydrochloride ophthalmic solution USP, 1%
Rx only
Amneal Pharmaceuticals LLC

1

 

1

NDC 69238-1746-8
Pilocarpine hydrochloride ophthalmic solution USP, 2%
Rx only
Amneal Pharmaceuticals LLC

1

 

1

NDC 69238-1747-8
Pilocarpine hydrochloride ophthalmic solution USP, 4%
Rx only
Amneal Pharmaceuticals LLC

1

1