Prescription drug · NDA
Voquezna (Vonoprazan fumarate) NDC 81520-100
Vonoprazan fumarate 13.36 mg/1 · Tablet · Oral · Phathom Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81520-100-30 | 81520010030 | 30 TABLET in 1 BOTTLE, PLASTIC (81520-100-30)Marketed from Nov 10, 2023 |
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)
- Voquezna
- Generic name (nonproprietary)
- vonoprazan fumarate
- Active ingredients
- Vonoprazan fumarate — 13.36 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Phathom Pharmaceuticals Inc.NDC labeler code 81520
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215151
- Marketing start
- Listing expires
- Identifiers
- Product ID 81520-100_120b19bf-feb2-43bd-8043-fca9521bebc1SPL ID 120b19bf-feb2-43bd-8043-fca9521bebc1SPL set ID 0cc52ac5-77ec-4d66-a770-762a1a960914RxCUI 2604800, 2669507, 2669513, 2669515UNII 4QW3X4AMLBUPC 0381520100303, 0381520200300
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
N481520010030followed by a unit qualifier and the quantityPackage 81520-0100-30. 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)
VOQUEZNA is indicated: for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults. to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults. for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults. in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori ( H. pylori ) infection in adults. in combination with amoxicillin for the treatment of H. pylori infection in adults. VOQUEZNA is a potassium-competitive acid blocker indicated: for healing of all grades of erosive esophagitis and relief…
Excerpt only. Read the full label for complete information.
About NDC 81520-100
- What is NDC 81520-100?
- 81520-100 is the product NDC for Voquezna (vonoprazan fumarate), Vonoprazan fumarate 13.36 mg/1 tablet, listed with the FDA by Phathom Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Voquezna (Vonoprazan fumarate).
- What is the active ingredient?
- Vonoprazan fumarate.
- Who is the labeler?
- Phathom Pharmaceuticals Inc., NDC labeler code 81520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Voquezna?
- 1 other product NDC are listed under this name. See all Voquezna NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Voquezna products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Voqueznavonoprazan fumarate | Vonoprazan fumarate 26.72 mg/1 | TabletOral | Phathom Pharmaceuticals Inc. | 81520-200 | 81520-0200-30 |
Other NDCs under NDA 215151
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Voqueznavonoprazan fumarate | Vonoprazan fumarate 26.72 mg/1 | TabletOral | Phathom Pharmaceuticals Inc. | 81520-200 |