NDC 61314-203-15
Pilocarpine Hydrochloride Ophthalmic Solution
1%
Rx only
STERILE
15 mL
SANDOZ
a Novartis Company
INGREDIENTS: Each mLcontains: Active: pilocarpine hydrochloride 1%.
Preservative: benzalkonium chloride 0.01%.
Inactives: 0.5% hypromellose 2910, boric acid, sodium chloride, sodium citrate, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.
USUAL DOSAGE: One drop in the eye(s) up to four times daily.
Read enclosed insert.
FOR TOPICAL OPHTHALMIC USE
STORAGE: Store at 15° to 25°C (59° to 77°F) and protect from freezing.
Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134
for Sandoz Inc.
Princeton, NJ 08540
Product of Brazil
9012999-0216
Rev. 03/2016
LOT:
EXP.:
NDC 61314-203-15
Pilocarpine Hydrochloride Ophthalmic Solution
1%
Rx only
STERILE 15 mL
SANDOZ
INGREDIENTS: Each mL contains:
Active: pilocarpine hydrochloride 1%.
Preservative: benzalkonium chloride 0.01%.
Inactives: 0.5% hypromellose 2910, boric acid, sodium chloride, sodium citrate, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.
USUAL DOSAGE: One drop in the eye(s) up to four times daily. Read enclosed insert.
FOR TOPICAL OPHTHALMIC USE ONLY.
STORAGE: Store at 15° to 25°C (59° to 77°F) and protect from freezing.
Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134
for Sandoz Inc.
Princeton, NJ 08540
Rev. 03/2016
H14248-0216
LOT:
EXP:
NDC 61314-204-15
Pilocarpine Hydrochloride Ophthalmic Solution
2%
Rx only
STERILE
15 mL
SANDOZ
a Novartis Company
INGREDIENTS: Each mLcontains: Active: pilocarpine hydrochloride 2%.
Preservative: benzalkonium chloride 0.01%.
Inactives: 0.5% hypromellose 2910, boric acid, sodium chloride, sodium citrate, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.
USUAL DOSAGE: One drop in the eye(s) up to four times daily.
Read enclosed insert.
FOR TOPICAL OPHTHALMIC USE
STORAGE: Store at 15° to 25°C (59° to 77°F) and protect from freezing.
Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134
for Sandoz Inc.
Princeton, NJ 08540
Product of Brazil
9012998-0216
Rev. 03/2016
LOT:
EXP.:
NDC 61314-204-15
Pilocarpine Hydrochloride Ophthalmic Solution
2%
Rx only
STERILE 15 mL
SANDOZ
INGREDIENTS: Each mL contains:
Active: pilocarpine hydrochloride 2%.
Preservative: benzalkonium chloride 0.01%.
Inactives: 0.5% hypromellose 2910, boric acid, sodium chloride, sodium citrate, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.
USUAL DOSAGE: One drop in the eye(s) up to four times daily. Read enclosed insert.
FOR TOPICAL OPHTHALMIC USE ONLY.
STORAGE: Store at 15° to 25°C (59° to 77°F) and protect from freezing.
Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134
for Sandoz Inc.
Princeton, NJ 08540
Rev. 03/2016
H14247-0216
LOT:
EXP:
NDC 61314-206-15
Pilocarpine Hydrochloride Ophthalmic Solution
4%
Rx only
STERILE
15 mL
SANDOZ
a Novartis Company
INGREDIENTS: Each mLcontains: Active: pilocarpine hydrochloride 4%.
Preservative: benzalkonium chloride 0.01%.
Inactives: 0.5% hypromellose 2910, boric acid, sodium chloride, sodium citrate, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.
USUAL DOSAGE: One drop in the eye(s) up to four times daily.
Read enclosed insert.
FOR TOPICAL OPHTHALMIC USE
STORAGE: Store at 15° to 25°C (59° to 77°F) and protect from freezing.
Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134
for Sandoz Inc.
Princeton, NJ 08540
Product of Brazil
9013021-0216
Rev. 03/2016
LOT:
EXP.:
NDC 61314-206-15
Pilocarpine Hydrochloride Ophthalmic Solution
4%
Rx only
STERILE 15 mL
SANDOZ
INGREDIENTS: Each mL contains:
Active: pilocarpine hydrochloride 4%.
Preservative: benzalkonium chloride 0.01%.
Inactives: 0.5% hypromellose 2910, boric acid, sodium chloride, sodium citrate, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.
USUAL DOSAGE: One drop in the eye(s) up to four times daily. Read enclosed insert.
FOR TOPICAL OPHTHALMIC USE ONLY.
STORAGE: Store at 15° to 25°C (59° to 77°F) and protect from freezing.
Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134
for Sandoz Inc.
Princeton, NJ 08540
Rev. 03/2016
H14252-0216
LOT:
EXP:
PILOCARPINE HYDROCHLORIDE
pilocarpine hydrochloride solution/ drops |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:61314-203 | | Route of Administration | OPHTHALMIC | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | Pilocarpine Hydrochloride (Pilocarpine) | Pilocarpine Hydrochloride | 10 mg in 1 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | Benzalkonium Chloride | | | Hypromellose 2910 (15 Mpa.s) | | | Boric Acid | | | Sodium Citrate | | | Sodium Chloride | | | Hydrochloric Acid | | | Sodium Hydroxide | | | Water | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:61314-203-15 | 1 BOTTLE in 1 CARTON | | 1 | | 15 mL in 1 BOTTLE | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA authorized generic | NDA200890 | 02/21/1996 | | |
PILOCARPINE HYDROCHLORIDE
pilocarpine hydrochloride solution/ drops |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:61314-204 | | Route of Administration | OPHTHALMIC | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | Pilocarpine Hydrochloride (Pilocarpine) | Pilocarpine Hydrochloride | 20 mg in 1 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | Benzalkonium Chloride | | | Hypromellose 2910 (15 Mpa.s) | | | Boric Acid | | | Sodium Citrate | | | Hydrochloric Acid | | | Sodium Hydroxide | | | Water | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:61314-204-15 | 1 BOTTLE in 1 CARTON | | 1 | | 15 mL in 1 BOTTLE | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA authorized generic | NDA200890 | 02/21/1996 | | |
PILOCARPINE HYDROCHLORIDE
pilocarpine hydrochloride solution/ drops |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:61314-206 | | Route of Administration | OPHTHALMIC | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | Pilocarpine Hydrochloride (Pilocarpine) | Pilocarpine Hydrochloride | 40 mg in 1 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | Benzalkonium Chloride | | | Hypromellose 2910 (15 Mpa.s) | | | Boric Acid | | | Sodium Citrate | | | Hydrochloric Acid | | | Sodium Hydroxide | | | Water | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:61314-206-15 | 1 BOTTLE in 1 CARTON | | 1 | | 15 mL in 1 BOTTLE | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA authorized generic | NDA200890 | 02/21/1996 | | |
| Labeler - Sandoz Inc. (005387188) |
| Registrant - Alcon Research Ltd (007672236) |
| Establishment |
| Name | Address | ID/FEI | Operations |
| Alcon Research Ltd | | 007672236 | manufacture(61314-203, 61314-204, 61314-206) |
Revised: 07/2016 Sandoz Inc.
