xuriden

Generic: uridine triacetate

Labeler: btg international inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xuriden
Generic Name uridine triacetate
Labeler btg international inc
Dosage Form GRANULE
Routes
ORAL
Active Ingredients

uridine triacetate 951 mg/g

Manufacturer
BTG International Inc

Identifiers & Regulatory

Product NDC 50633-330
Product ID 50633-330_2e671cf8-09be-ac40-e063-6294a90aaf8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208169
Listing Expiration 2026-12-31
Marketing Start 2024-05-31

Pharmacologic Class

Classes
analogs/derivatives [chemical/ingredient] pyrimidine analog [epc] pyrimidines [chemical/ingredient]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50633330
Hyphenated Format 50633-330

Supplemental Identifiers

RxCUI
1665467 1665473
UPC
0350633330020
UNII
2WP61F175M

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 xuriden (source: ndc)
Generic Name uridine triacetate (source: ndc)
Application Number NDA208169 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 951 mg/g
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (50633-330-30) / 2 g in 1 PACKET (50633-330-02)
source: ndc

Packages (1)

50633-330-30 30 PACKET in 1 CARTON (50633-330-30) / 2 g in 1 PACKET (50633-330-02)

Ingredients (1)

uridine triacetate (951 mg/g)

Linked Drug Pages (1)

XURIDEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2e671cf8-09be-ac40-e063-6294a90aaf8f", "openfda": {"upc": ["0350633330020"], "unii": ["2WP61F175M"], "rxcui": ["1665467", "1665473"], "spl_set_id": ["88ca4d2b-3905-474b-9fd6-c81474f2fb4b"], "manufacturer_name": ["BTG International Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (50633-330-30)  / 2 g in 1 PACKET (50633-330-02)", "package_ndc": "50633-330-30", "marketing_start_date": "20240531"}], "brand_name": "XURIDEN", "product_id": "50633-330_2e671cf8-09be-ac40-e063-6294a90aaf8f", "dosage_form": "GRANULE", "pharm_class": ["Analogs/Derivatives [Chemical/Ingredient]", "Pyrimidine Analog [EPC]", "Pyrimidines [Chemical/Ingredient]"], "product_ndc": "50633-330", "generic_name": "uridine triacetate", "labeler_name": "BTG International Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XURIDEN", "active_ingredients": [{"name": "URIDINE TRIACETATE", "strength": "951 mg/g"}], "application_number": "NDA208169", "marketing_category": "NDA", "marketing_start_date": "20240531", "listing_expiration_date": "20261231"}