Prescription drug · NDA
Qelbree (Viloxazine hydrochloride) NDC 17772-131
Viloxazine hydrochloride 100 mg/1 · Capsule, Extended release · Oral · Supernus Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17772-131-01 | 17772013101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-01)Marketed from Apr 2, 2021 | |
| 17772-131-07 | 17772013107 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-07)Marketed from Apr 2, 2021 · Sample package | |
| 17772-131-30 | 17772013130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-30)Marketed from Apr 2, 2021 | |
| 17772-131-60 | 17772013160 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-60)Marketed from Apr 2, 2021 | |
| 17772-131-90 | 17772013190 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-90)Marketed from Apr 2, 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)
- Qelbree
- Generic name (nonproprietary)
- viloxazine hydrochloride
- Active ingredients
- Viloxazine hydrochloride — 100 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Supernus Pharmaceuticals, IncNDC labeler code 17772
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211964
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2B6 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 17772-131_5b89031c-41a3-d7e0-e063-6294a90af6fbSPL ID 5b89031c-41a3-d7e0-e063-6294a90af6fb
- Pharmacologic class
- Norepinephrine Reuptake 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
N417772013101followed by a unit qualifier and the quantityPackage 17772-0131-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 17772-131
- What is NDC 17772-131?
- 17772-131 is the product NDC for Qelbree (viloxazine hydrochloride), Viloxazine hydrochloride 100 mg/1 capsule, extended release, listed with the FDA by Supernus Pharmaceuticals, Inc. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Qelbree (Viloxazine hydrochloride).
- What is the active ingredient?
- Viloxazine hydrochloride.
- Who is the labeler?
- Supernus Pharmaceuticals, Inc, NDC labeler code 17772. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Qelbree?
- 2 other product NDCs are listed under this name. See all Qelbree NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Qelbree products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Qelbreeviloxazine hydrochloride | Viloxazine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Supernus Pharmaceuticals, Inc | 17772-132 | 17772-0132-0117772-0132-0717772-0132-30+2 more |
| Qelbreeviloxazine hydrochloride | Viloxazine hydrochloride 200 mg/1 | Capsule, Extended releaseOral | Supernus Pharmaceuticals, Inc | 17772-133 | 17772-0133-0117772-0133-0717772-0133-30+2 more |
Other NDCs under NDA 211964
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 |
|---|---|---|---|---|
| Qelbreeviloxazine hydrochloride | Viloxazine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Supernus Pharmaceuticals, Inc | 17772-132 |
| Qelbreeviloxazine hydrochloride | Viloxazine hydrochloride 200 mg/1 | Capsule, Extended releaseOral | Supernus Pharmaceuticals, Inc | 17772-133 |