cystadrops

Generic: cysteamine hydrochloride

Labeler: recordati rare diseases, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cystadrops
Generic Name cysteamine hydrochloride
Labeler recordati rare diseases, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

cysteamine hydrochloride 3.5 mg/mL

Manufacturer
RECORDATI RARE DISEASES, INC.

Identifiers & Regulatory

Product NDC 55292-410
Product ID 55292-410_34dba967-28b4-4fc8-876d-2e30d32a0f95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211302
Listing Expiration 2026-12-31
Marketing Start 2020-08-19

Pharmacologic Class

Classes
cystine depleting agent [epc] cystine disulfide reduction [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55292410
Hyphenated Format 55292-410

Supplemental Identifiers

UNII
IF1B771SVB

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cystadrops (source: ndc)
Generic Name cysteamine hydrochloride (source: ndc)
Application Number NDA211302 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 BOX (55292-410-05) / 5 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

55292-410-05 1 BOTTLE, GLASS in 1 BOX (55292-410-05) / 5 mL in 1 BOTTLE, GLASS

Ingredients (1)

cysteamine hydrochloride (3.5 mg/mL)

Linked Drug Pages (1)

CYSTADROPS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "34dba967-28b4-4fc8-876d-2e30d32a0f95", "openfda": {"unii": ["IF1B771SVB"], "spl_set_id": ["5d2bcce3-9b89-4141-aeb7-db00449047f5"], "manufacturer_name": ["RECORDATI RARE DISEASES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 BOX (55292-410-05)  / 5 mL in 1 BOTTLE, GLASS", "package_ndc": "55292-410-05", "marketing_start_date": "20200819"}], "brand_name": "CYSTADROPS", "product_id": "55292-410_34dba967-28b4-4fc8-876d-2e30d32a0f95", "dosage_form": "SOLUTION", "pharm_class": ["Cystine Depleting Agent [EPC]", "Cystine Disulfide Reduction [MoA]"], "product_ndc": "55292-410", "generic_name": "cysteamine hydrochloride", "labeler_name": "RECORDATI RARE DISEASES, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYSTADROPS", "active_ingredients": [{"name": "CYSTEAMINE HYDROCHLORIDE", "strength": "3.5 mg/mL"}], "application_number": "NDA211302", "marketing_category": "NDA", "marketing_start_date": "20200819", "listing_expiration_date": "20261231"}