CYSTADROPS (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55292-410-05
Cystadrops ®
(cysteamine ophthalmic solution)
0.37 %
For Topical Ophthalmic Use
Rx only
1 x 5 mL
sterile
Recordati
Rare Diseases
GROUP

Manufactured by: Baccinex SA
Courroux, Switzerland
For: Recordati Rare Diseases Inc.
Lebanon, NJ 08833 U.S.A.
CDRCRT
LOT: 12345678A
EXP: 20XX/MM
S/N: 123456789012
GTIN: 12345678901234

carton
(click image for full-size original)

NDC 55292-410-05
Rx only
Cystadrops ®
(cysteamine ophthalmic solution)
0.37 %
5 mL
sterile
Recordati Rare Diseases Inc.
CDRLBL
Lot: EXP: YYYY/MM

label
(click image for full-size original)
CYSTADROPS cysteamine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55292-410
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cysteamine Hydrochloride (Cysteamine) Cysteamine Hydrochloride 3.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride
Carboxymethylcellulose Sodium, Unspecified
Citric Acid Monohydrate
Edetate Disodium
Hydrochloric Acid
Sodium Hydroxide
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55292-410-05 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
1 5 mL in 1 BOTTLE, GLASS This package is contained within the BOX (55292-410-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211302 08/19/2020
Labeler — RECORDATI RARE DISEASES, INC. (181699406)
Establishment
Name Address ID/FEI Operations
Baccinex SA 480767297 manufacture (55292-410)

Revised: 10/2022 RECORDATI RARE DISEASES, INC.

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