Prescription drug · NDA
Rybelsus (oral semaglutide) NDC 0169-4303
Semaglutide 3 mg/1 · Tablet · Oral · Novo Nordisk Pharmaceutical Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-4303-30 | 00169430330 | 30 TABLET in 1 BOTTLE, PLASTIC (0169-4303-30)Marketed from Oct 4, 2021 | |
| 0169-4303-99 | 00169430399 | 30 TABLET in 1 BOTTLE, PLASTIC (0169-4303-99)Marketed from Oct 4, 2021 · Sample package |
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)
- Rybelsus
- Generic name (nonproprietary)
- oral semaglutide
- Active ingredients
- Semaglutide — 3 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213051
- Marketing start
- Listing expires
- Other FDA classes
- Glucagon-Like Peptide 1 (Chemical structure)Glucagon-like Peptide-1 (GLP-1) Agonists (Mechanism)
- Identifiers
- Product ID 0169-4303_6834044a-22f1-4f35-b846-b3448ee84c16SPL ID 6834044a-22f1-4f35-b846-b3448ee84c16SPL set ID 27f15fac-7d98-4114-a2ec-92494a91da98RxCUI 2200644, 2200650, 2200652, 2200654, 2200656, 2200658, 2707547, 2707549, 2707551, 2707553, 2707555, 2707557, 2736944, 2736946, 2736948UNII 53AXN4NNHX
- Pharmacologic class
- GLP-1 Receptor Agonist
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
N400169430330followed by a unit qualifier and the quantityPackage 00169-4303-30. 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)
RYBELSUS and OZEMPIC tablets are indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. RYBELSUS and OZEMPIC tablets are glucagon-like peptide-1 (GLP-1) receptor agonists indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke)…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 213051
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 |
|---|---|---|---|---|
| Ozempicoral semaglutide | Semaglutide 4 mg/1 | TabletOral | Novo Nordisk Pharmaceutical Industries, LP | 0169-1704 |
| Ozempicoral semaglutide | Semaglutide 9 mg/1 | TabletOral | Novo Nordisk Pharmaceutical Industries, LP | 0169-1709 |
| Ozempicoral semaglutide | Semaglutide 1.5 mg/1 | TabletOral | Novo Nordisk Pharmaceutical Industries, LP | 0169-1715 |
| Rybelsusoral semaglutide | Semaglutide 7 mg/1 | TabletOral | Novo Nordisk Pharmaceutical Industries, LP | 0169-4307 |
| Rybelsusoral semaglutide | Semaglutide 14 mg/1 | TabletOral | Novo Nordisk Pharmaceutical Industries, LP | 0169-4314 |