Prescription drug · NDA
Belsomra (Suvorexant) NDC 0006-0005
Suvorexant 5 mg/1 · Tablet, Film coated · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-0005-13 | 00006000513 | 1 BLISTER PACK in 1 CASE (0006-0005-13) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 29, 2014 | |
| 0006-0005-30 | 00006000530 | 3 CASE in 1 CARTON (0006-0005-30) / 1 BLISTER PACK in 1 CASE (0006-0005-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 29, 2014 |
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)
- Belsomra
- Generic name (nonproprietary)
- suvorexant
- Active ingredients
- Suvorexant — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 0006
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204569
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Cytochrome P450 3A Inhibitors (Mechanism)Orexin Receptor Antagonists (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0006-0005_21306af5-e07a-4f8e-8f59-3e0aacc53102SPL ID 21306af5-e07a-4f8e-8f59-3e0aacc53102SPL set ID e5b72731-1acb-45b7-9c13-290ad12d3951RxCUI 1547104, 1547110, 1547112, 1547114, 1547116, 1547118, 1547573, 1547575UNII 081L192FO9
- Pharmacologic class
- Orexin Receptor Antagonist
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
N400006000513followed by a unit qualifier and the quantityPackage 00006-0005-13. 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 .
Indications (excerpt from the label)
BELSOMRA ® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 0006-0005
- What is NDC 0006-0005?
- 0006-0005 is the product NDC for Belsomra (suvorexant), Suvorexant 5 mg/1 tablet, film coated, listed with the FDA by Merck Sharp & Dohme LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Belsomra (Suvorexant).
- What is the active ingredient?
- Suvorexant.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Belsomra?
- 3 other product NDCs are listed under this name. See all Belsomra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Belsomra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Belsomrasuvorexant | Suvorexant 20 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0335 | 00006-0335-1300006-0335-30 |
| Belsomrasuvorexant | Suvorexant 10 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0033 | 00006-0033-1300006-0033-30 |
| Belsomrasuvorexant | Suvorexant 15 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0325 | 00006-0325-1300006-0325-30 |
Other NDCs under NDA 204569
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 |
|---|---|---|---|---|
| Belsomrasuvorexant | Suvorexant 20 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0335 |
| Belsomrasuvorexant | Suvorexant 10 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0033 |
| Belsomrasuvorexant | Suvorexant 15 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0325 |