Prescription drug · NDA
Singulair (Montelukast sodium) NDC 78206-170
Montelukast sodium 4 mg/1 · Tablet, Chewable · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-170-01 | 7820601700178206017001 | 30 TABLET, CHEWABLE in 1 BOTTLE (78206-170-01)Marketed from Jun 1, 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)
- Singulair
- Generic name (nonproprietary)
- montelukast sodium
- Active ingredients
- Montelukast sodium — 4 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Organon LLCNDC labeler code 78206
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020830
- Marketing start
- Listing expires
- Other FDA classes
- Leukotriene Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 78206-170_57a12189-3bb3-4a5d-b5fe-fc57db87c134SPL ID 57a12189-3bb3-4a5d-b5fe-fc57db87c134SPL set ID 482dcc92-b47f-4ea6-854a-f5ac2aea7842RxCUI 153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406UNII U1O3J18SFLUPC 0378206173010, 0378206170019
- Pharmacologic class
- Leukotriene 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
N478206017001followed by a unit qualifier and the quantityPackage 78206-0170-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
SINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). Limitations of Use: Not indicated to treat an acute asthma attack ( 5.2 ). 1.1 Asthma SINGULAIR ® is indicated for the prophylaxis and ch…
Excerpt only. Read the full label for complete information.
About NDC 78206-170
- What is NDC 78206-170?
- 78206-170 is the product NDC for Singulair (montelukast sodium), Montelukast sodium 4 mg/1 tablet, chewable, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Singulair (Montelukast sodium).
- What is the active ingredient?
- Montelukast sodium.
- Who is the labeler?
- Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Singulair?
- 3 other product NDCs are listed under this name. See all Singulair NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Singulair products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Singulairmontelukast sodium | Montelukast sodium 4 mg/1 | GranuleOral | Organon LLC | 78206-171 | 78206-0171-01 |
| Singulairmontelukast sodium | Montelukast sodium 10 mg/1 | Tablet, Film coatedOral | Organon LLC | 78206-172 | 78206-0172-0178206-0172-02 |
| Singulairmontelukast sodium | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | Organon LLC | 78206-173 | 78206-0173-01 |
Other NDCs under NDA 020830
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 |
|---|---|---|---|---|
| Singulairmontelukast sodium | Montelukast sodium 5 mg/1 | Tablet, ChewableOral | Organon LLC | 78206-173 |