Prescription drug · NDA
Ozempic (Oral semaglutide) NDC 0169-1715
Semaglutide 1.5 mg/1 · Tablet · Oral · Novo Nordisk Pharmaceutical Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-1715-30 | 00169171530 | 30 TABLET in 1 BOTTLE, PLASTIC (0169-1715-30)Marketed from Apr 27, 2026 | |
| 0169-1715-90 | 00169171590 | 30 TABLET in 1 BOTTLE, PLASTIC (0169-1715-90)Marketed from Apr 27, 2026 · 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)
- Ozempic
- Generic name (nonproprietary)
- oral semaglutide
- Active ingredients
- Semaglutide — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Novo Nordisk Pharmaceutical Industries, LPNDC labeler code 0169
- 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 0169-1715_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
N400169171530followed by a unit qualifier and the quantityPackage 00169-1715-30. 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.
About NDC 0169-1715
- What is NDC 0169-1715?
- 0169-1715 is the product NDC for Ozempic (oral semaglutide), Semaglutide 1.5 mg/1 tablet, listed with the FDA by Novo Nordisk Pharmaceutical Industries, LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ozempic (Oral semaglutide).
- What is the active ingredient?
- Semaglutide.
- Who is the labeler?
- Novo Nordisk Pharmaceutical Industries, LP, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ozempic?
- 8 other product NDCs are listed under this name. See all Ozempic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ozempic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ozempicoral semaglutide | Semaglutide 4 mg/1 | TabletOral | Novo Nordisk Pharmaceutical Industries, LP | 0169-1704 | 00169-1704-30 |
| Ozempicoral semaglutide | Semaglutide 9 mg/1 | TabletOral | Novo Nordisk Pharmaceutical Industries, LP | 0169-1709 | 00169-1709-30 |
| Ozempicsemaglutide | Semaglutide .68 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-8027 | 50090-8027-00 |
| Ozempicsemaglutide | Semaglutide .68 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharmaceutical Industries, LP | 0169-4181 | 00169-4181-1300169-4181-97 |
| Ozempicsemaglutide | Semaglutide 2.68 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-6051 | 50090-6051-00 |
| Ozempicsemaglutide | Semaglutide 2.68 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharmaceutical Industries, LP | 0169-4772 | 00169-4772-1200169-4772-97 |
| Ozempicsemaglutide | Semaglutide 1.34 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharmaceutical Industries, LP | 0169-4130 | 00169-4130-13 |
| Ozempicsemaglutide | Semaglutide 1.34 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-5949 | 50090-5949-00 |
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 |
| Rybelsusoral semaglutide | Semaglutide 3 mg/1 | TabletOral | Novo Nordisk Pharmaceutical Industries, LP | 0169-4303 |
| 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 |