procysbi

Generic: cysteamine bitartrate

Labeler: horizon therapeutics usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name procysbi
Generic Name cysteamine bitartrate
Labeler horizon therapeutics usa, inc.
Dosage Form GRANULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

cysteamine bitartrate 75 mg/1

Manufacturer
Horizon Therapeutics USA, Inc.

Identifiers & Regulatory

Product NDC 75987-140
Product ID 75987-140_374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213491
Listing Expiration 2026-12-31
Marketing Start 2020-02-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75987140
Hyphenated Format 75987-140

Supplemental Identifiers

RxCUI
1421467 1421473 1421475 1421477 2284510 2284514 2284515 2284516
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 procysbi (source: ndc)
Generic Name cysteamine bitartrate (source: ndc)
Application Number NDA213491 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 60 PACKET in 1 CARTON (75987-140-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET
  • 120 PACKET in 1 CARTON (75987-140-14) / 1 GRANULE, DELAYED RELEASE in 1 PACKET
source: ndc

Packages (2)

75987-140-13 60 PACKET in 1 CARTON (75987-140-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET 75987-140-14 120 PACKET in 1 CARTON (75987-140-14) / 1 GRANULE, DELAYED RELEASE in 1 PACKET

Ingredients (1)

cysteamine bitartrate (75 mg/1)

Linked Drug Pages (1)

PROCYSBI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f", "openfda": {"unii": ["QO84GZ3TST"], "rxcui": ["1421467", "1421473", "1421475", "1421477", "2284510", "2284514", "2284515", "2284516"], "spl_set_id": ["d3a3ec28-f746-463a-bb92-3bc8826db09e"], "manufacturer_name": ["Horizon Therapeutics USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 PACKET in 1 CARTON (75987-140-13)  / 1 GRANULE, DELAYED RELEASE in 1 PACKET", "package_ndc": "75987-140-13", "marketing_start_date": "20200214"}, {"sample": false, "description": "120 PACKET in 1 CARTON (75987-140-14)  / 1 GRANULE, DELAYED RELEASE in 1 PACKET", "package_ndc": "75987-140-14", "marketing_start_date": "20200214"}], "brand_name": "PROCYSBI", "product_id": "75987-140_374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f", "dosage_form": "GRANULE, DELAYED RELEASE", "pharm_class": ["Cystine Depleting Agent [EPC]", "Cystine Disulfide Reduction [MoA]"], "product_ndc": "75987-140", "generic_name": "Cysteamine bitartrate", "labeler_name": "Horizon Therapeutics USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROCYSBI", "active_ingredients": [{"name": "CYSTEAMINE BITARTRATE", "strength": "75 mg/1"}], "application_number": "NDA213491", "marketing_category": "NDA", "marketing_start_date": "20200214", "listing_expiration_date": "20261231"}