Prescription drug · NDA
Oxbryta (Voxelotor) NDC 72786-111
Voxelotor 300 mg/1 · Tablet, For suspension · Oral · Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72786-111-02 | 7278601110272786011102 | 60 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC (72786-111-02)Marketed from Dec 17, 2021 | |
| 72786-111-03 | 7278601110372786011103 | 90 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC (72786-111-03)Marketed from Dec 17, 2021 |
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)
- Oxbryta
- Generic name (nonproprietary)
- voxelotor
- Active ingredients
- Voxelotor — 300 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.NDC labeler code 72786
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216157
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Hemoglobin S Polymerization Inhibitors (Mechanism)
- Identifiers
- Product ID 72786-111_e27a3e07-438e-49d3-aae3-095e9379c7b4SPL ID e27a3e07-438e-49d3-aae3-095e9379c7b4SPL set ID 3c557fac-29ec-483f-b691-8a935d4decc3RxCUI 2265683, 2265689, 2588070, 2588074, 2619427, 2619428UNII 3ZO554A4Q8UPC 0372786111035
- Pharmacologic class
- Hemoglobin S Polymerization 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
N472786011102followed by a unit qualifier and the quantityPackage 72786-0111-02. 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)
OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). OXBRYTA is a hemoglobin S polymerization inhibitor indicated for the treatment of sickle cell disease in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent up…
Excerpt only. Read the full label for complete information.
About NDC 72786-111
- What is NDC 72786-111?
- 72786-111 is the product NDC for Oxbryta (voxelotor), Voxelotor 300 mg/1 tablet, for suspension, listed with the FDA by Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxbryta (Voxelotor).
- What is the active ingredient?
- Voxelotor.
- Who is the labeler?
- Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc., NDC labeler code 72786. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxbryta?
- 2 other product NDCs are listed under this name. See all Oxbryta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxbryta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxbrytavoxelotor | Voxelotor 500 mg/1 | Tablet, Film coatedOral | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. | 72786-101 | 72786-0101-01 |
| Oxbrytavoxelotor | Voxelotor 300 mg/1 | Tablet, Film coatedOral | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. | 72786-102 | 72786-0102-0272786-0102-03 |