NDC Code(s) : 17478-100-02, 17478-100-10, 17478-100-12, 17478-097-02, 17478-097-10, 17478-097-12
Packager : Akorn

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cyclopentolate HydrochlorideCyclopentolate Hydrochloride SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-100
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cyclopentolate Hydrochloride(UNII: 736I6971TE)
(Cyclopentolate - UNII:I76F4SHP7J) 		Cyclopentolate Hydrochloride10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride(UNII: F5UM2KM3W7)
boric acid(UNII: R57ZHV85D4)
edetate disodium(UNII: 7FLD91C86K)
potassium chloride(UNII: 660YQ98I10)
sodium carbonate(UNII: 45P3261C7T)
hydrochloric acid(UNII: QTT17582CB)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:17478-100-021 in 1 CARTON 13/01/1997
12 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
2NDC:17478-100-101 in 1 CARTON 13/01/1997
25 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
3NDC:17478-100-121 in 1 CARTON 13/01/1997
315 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040164 01/13/1997 03/31/2024
Cyclopentolate HydrochlorideCyclopentolate Hydrochloride SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-097
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cyclopentolate Hydrochloride(UNII: 736I6971TE)
(Cyclopentolate - UNII:I76F4SHP7J) 		Cyclopentolate Hydrochloride20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride(UNII: F5UM2KM3W7)
boric acid(UNII: R57ZHV85D4)
edetate disodium(UNII: 7FLD91C86K)
sodium carbonate(UNII: 45P3261C7T)
hydrochloric acid(UNII: QTT17582CB)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:17478-097-021 in 1 CARTON 13/01/1997
12 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
2NDC:17478-097-101 in 1 CARTON 13/01/1997
25 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
3NDC:17478-097-121 in 1 CARTON 13/01/1997
315 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040165 01/13/1997 03/31/2024

LABELER - Akorn(117693100)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-100-02

Cyclopentolate

Hydrochloride

Ophthalmic

Solution, USP

1%

For Topical

Ophthalmic Use Only

Rx only 2 mL

cyc01-0007-02

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-100-02

Cyclopentolate

Hydrochloride

Ophthalmic

Solution, USP

1%

For Topical

Ophthalmic Use Only

2 mL

Rx only Akorn logo

cyc01-0007-03

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-097-10

Cyclopentolate

Hydrochloride

Ophthalmic

Solution, USP

2%

5 mL

Rx only Sterile

cyc01-0007-04

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-097-10

Cyclopentolate

Hydrochloride

Ophthalmic

Solution, USP

2%

5 mL

Sterile

Rx only Akorn logo

cyc01-0007-05