cystagon

Generic: cysteamine bitartrate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cystagon
Generic Name cysteamine bitartrate
Labeler mylan pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cysteamine bitartrate 150 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-9045
Product ID 0378-9045_29dfd298-96ed-4a5f-a573-b24f5ffa618b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020392
Listing Expiration 2026-12-31
Marketing Start 2005-04-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03789045
Hyphenated Format 0378-9045

Supplemental Identifiers

RxCUI
209788 209789 309636 309637
UPC
0303789045058 0303789040053
UNII
QO84GZ3TST

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 cystagon (source: ndc)
Generic Name cysteamine bitartrate (source: ndc)
Application Number NDA020392 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)
source: ndc

Packages (1)

0378-9045-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)

Ingredients (1)

cysteamine bitartrate (150 mg/1)

Linked Drug Pages (1)

Cystagon ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "29dfd298-96ed-4a5f-a573-b24f5ffa618b", "openfda": {"upc": ["0303789045058", "0303789040053"], "unii": ["QO84GZ3TST"], "rxcui": ["209788", "209789", "309636", "309637"], "spl_set_id": ["f495b76d-96c6-48e5-8fa3-30a4336628eb"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)", "package_ndc": "0378-9045-05", "marketing_start_date": "20050411"}], "brand_name": "Cystagon", "product_id": "0378-9045_29dfd298-96ed-4a5f-a573-b24f5ffa618b", "dosage_form": "CAPSULE", "pharm_class": ["Cystine Depleting Agent [EPC]", "Cystine Disulfide Reduction [MoA]"], "product_ndc": "0378-9045", "generic_name": "cysteamine bitartrate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cystagon", "active_ingredients": [{"name": "CYSTEAMINE BITARTRATE", "strength": "150 mg/1"}], "application_number": "NDA020392", "marketing_category": "NDA", "marketing_start_date": "20050411", "listing_expiration_date": "20261231"}