Prescription drug · NDA
Sunosi (Solriamfetol) NDC 81968-350
Solriamfetol 75 mg/1 · Tablet, Film coated · Oral · Axsome Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81968-350-01 | 81968035001 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-350-01)Marketed from Jun 2, 2022 | |
| 81968-350-07 | 81968035007 | 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)Marketed from Jun 2, 2022 · Sample package | |
| 81968-350-10 | 81968035010 | 10 BLISTER PACK in 1 CARTON (81968-350-10) / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)Marketed from Jun 2, 2022 · Sample package |
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)
- Sunosi
- Generic name (nonproprietary)
- solriamfetol
- Active ingredients
- Solriamfetol — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Axsome Therapeutics, Inc.NDC labeler code 81968
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211230
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Dopamine Uptake Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 81968-350_f0a0a507-33cd-4ab1-b438-12996fae6ae1SPL ID f0a0a507-33cd-4ab1-b438-12996fae6ae1SPL set ID 362f206b-73e7-4009-8c34-5a9df55679abRxCUI 2121756, 2121758, 2121764, 2173841UNII 939U7C91AIUPC 0381968350018, 0381968351015
- Pharmacologic class
- Dopamine and 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
N481968035001followed by a unit qualifier and the quantityPackage 81968-0350-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies ( 14 )] . Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities. SUNOSI is a dopamine and norepinephrine reuptake inhibitor (DNRI) ind…
Excerpt only. Read the full label for complete information.
About NDC 81968-350
- What is NDC 81968-350?
- 81968-350 is the product NDC for Sunosi (solriamfetol), Solriamfetol 75 mg/1 tablet, film coated, listed with the FDA by Axsome Therapeutics, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sunosi (Solriamfetol).
- What is the active ingredient?
- Solriamfetol.
- Who is the labeler?
- Axsome Therapeutics, Inc., NDC labeler code 81968. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sunosi?
- 1 other product NDC are listed under this name. See all Sunosi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sunosi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sunosisolriamfetol | Solriamfetol 150 mg/1 | Tablet, Film coatedOral | Axsome Therapeutics, Inc. | 81968-351 | 81968-0351-0181968-0351-0781968-0351-10 |
Other NDCs under NDA 211230
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 |
|---|---|---|---|---|
| Sunosisolriamfetol | Solriamfetol 150 mg/1 | Tablet, Film coatedOral | Axsome Therapeutics, Inc. | 81968-351 |