Prescription drug · NDA
Vistogard (Uridine triacetate) NDC 50633-220
Uridine triacetate 951 mg/g · Granule · Oral · BTG International Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50633-220-04 | 5063302200450633022004 | 4 PACKET in 1 CARTON (50633-220-04) / 10 g in 1 PACKET (50633-220-10)Marketed from Jul 31, 2024 | |
| 50633-220-20 | 5063302202050633022020 | 20 PACKET in 1 CARTON (50633-220-20) / 10 g in 1 PACKET (50633-220-10)Marketed from Jul 31, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Vistogard
- Generic name (nonproprietary)
- uridine triacetate
- Active ingredients
- Uridine triacetate — 951 mg/g
- Dosage form
- Granule
- Route
- Oral
- Labeler
- BTG International IncNDC labeler code 50633
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208159
- Marketing start
- Listing expires
- Other FDA classes
- Analogs/Derivatives (Chemical/Ingredient)Pyrimidines (Chemical/Ingredient)
- Identifiers
- Product ID 50633-220_4e4e69bd-abb4-4632-e063-6394a90ab642SPL ID 4e4e69bd-abb4-4632-e063-6394a90ab642SPL set ID 269f7363-63ed-444e-85f1-f0009e44818bRxCUI 1739794, 1739800UNII 2WP61F175MUPC 0350633220109
- Pharmacologic class
- Pyrimidine Analog
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450633022004followed by a unit qualifier and the quantityPackage 50633-0220-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
VISTOGARD ® is indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration. VISTOGARD ® is a pyrimidine analog indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onse…
Excerpt only. Read the full label for complete information.
About NDC 50633-220
- What is NDC 50633-220?
- 50633-220 is the product NDC for Vistogard (uridine triacetate), Uridine triacetate 951 mg/g granule, listed with the FDA by BTG International Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vistogard (Uridine triacetate).
- What is the active ingredient?
- Uridine triacetate.
- Who is the labeler?
- BTG International Inc, NDC labeler code 50633. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vistogard?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.