Prescription drug · NDA
Jesduvroq (Daprodustat) NDC 0173-0911
Daprodustat 6 mg/1 · Tablet, Film coated · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0911-13 | 00173091113 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0911-13)Marketed from Feb 1, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Jesduvroq
- Generic name (nonproprietary)
- daprodustat
- Active ingredients
- Daprodustat — 6 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216951
- Marketing start
- Marketing end
- Other FDA classes
- Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors (Mechanism)
- Identifiers
- Product ID 0173-0911_d52a823a-35bd-4c6a-a016-4b4f21a43d7dSPL ID d52a823a-35bd-4c6a-a016-4b4f21a43d7dSPL set ID d82aa06e-5a33-4844-99b7-4701313455a4RxCUI 2628215, 2628221, 2628223, 2628225, 2628227, 2628229, 2628231, 2628233, 2628235, 2628237UNII JVR38ZM64BUPC 0301730906137, 0301730903136, 0301730897138
- Pharmacologic class
- Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor
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
N400173091113followed by a unit qualifier and the quantityPackage 00173-0911-13. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
JESDUVROQ is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Limitations of Use JESDUVROQ has not been shown to improve quality of life, fatigue, or patient well-being. JESDUVROQ is not indicated for use: • As a substitute for red blood cell transfusions in patients who require immediate correction of anemia. • For treatment of anemia of chronic kidney disease in patients who are not on dialysis. JESDUVROQ is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least fou…
Excerpt only. Read the full label for complete information.
About NDC 0173-0911
- What is NDC 0173-0911?
- 0173-0911 is the product NDC for Jesduvroq (daprodustat), Daprodustat 6 mg/1 tablet, film coated, listed with the FDA by GlaxoSmithKline LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jesduvroq (Daprodustat).
- What is the active ingredient?
- Daprodustat.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jesduvroq?
- 4 other product NDCs are listed under this name. See all Jesduvroq NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Jesduvroq products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Jesduvroqdaprodustat | Daprodustat 1 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0897 | 00173-0897-13 |
| Jesduvroqdaprodustat | Daprodustat 2 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0903 | 00173-0903-13 |
| Jesduvroqdaprodustat | Daprodustat 4 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0906 | 00173-0906-13 |
| Jesduvroqdaprodustat | Daprodustat 8 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0914 | 00173-0914-13 |
Other NDCs under NDA 216951
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 |
|---|---|---|---|---|
| Jesduvroqdaprodustat | Daprodustat 1 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0897 |
| Jesduvroqdaprodustat | Daprodustat 2 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0903 |
| Jesduvroqdaprodustat | Daprodustat 4 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0906 |
| Jesduvroqdaprodustat | Daprodustat 8 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0914 |