Prescription drug · NDA
Ozempic (Semaglutide) NDC 0169-4181
Semaglutide .68 mg/mL · Injection, Solution · Subcutaneous · Novo Nordisk Pharmaceutical Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-4181-13 | 00169418113 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-4181-13) / 3 mL in 1 SYRINGE, PLASTIC (0169-4181-03)Marketed from Oct 7, 2022 | |
| 0169-4181-97 | 00169418197 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-4181-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-4181-90)Marketed from Oct 7, 2022 · 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)
- semaglutide
- Active ingredients
- Semaglutide — .68 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Novo Nordisk Pharmaceutical Industries, LPNDC labeler code 0169
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209637
- Marketing start
- Listing expires
- Other FDA classes
- Glucagon-Like Peptide 1 (Chemical structure)Glucagon-like Peptide-1 (GLP-1) Agonists (Mechanism)
- Identifiers
- Product ID 0169-4181_5e1477c5-c1b8-4fc5-af2a-83e5d356a77dSPL ID 5e1477c5-c1b8-4fc5-af2a-83e5d356a77d
- 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 codeMed-Code curated
No drug-specific HCPCS code in Med-Code’s directory for this product.
Med-Code's directory has no drug-specific HCPCS code for Ozempic. It is usually self-administered and billed by NDC through a pharmacy benefit.
If a payer accepts an unclassified code for it in a clinical setting, that would be J3490 (Unclassified drugs), with the NDC, quantity and often the invoice. Acceptance varies by payer.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400169418113followed by a unit qualifier and the quantityPackage 00169-4181-13. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0169-4181
- What is NDC 0169-4181?
- 0169-4181 is the product NDC for Ozempic (semaglutide), Semaglutide .68 mg/mL injection, solution, 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 (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 |
| Ozempicoral semaglutide | Semaglutide 1.5 mg/1 | TabletOral | Novo Nordisk Pharmaceutical Industries, LP | 0169-1715 | 00169-1715-3000169-1715-90 |
| Ozempicsemaglutide | Semaglutide .68 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-8027 | 50090-8027-00 |
| Ozempicsemaglutide | Semaglutide 2.68 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharmaceutical Industries, LP | 0169-4772 | 00169-4772-1200169-4772-97 |
| Ozempicsemaglutide | Semaglutide 2.68 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-6051 | 50090-6051-00 |
| Ozempicsemaglutide | Semaglutide 1.34 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-5949 | 50090-5949-00 |
| Ozempicsemaglutide | Semaglutide 1.34 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharmaceutical Industries, LP | 0169-4130 | 00169-4130-13 |
Other NDCs under NDA 209637
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 |
|---|---|---|---|---|
| Ozempicsemaglutide | Semaglutide 2.68 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharmaceutical Industries, LP | 0169-4772 |
| Ozempicsemaglutide | Semaglutide 1.34 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-5949 |
| Ozempicsemaglutide | Semaglutide 2.68 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-6051 |
| Ozempicsemaglutide | Semaglutide 1.34 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharmaceutical Industries, LP | 0169-4130 |
| Ozempicsemaglutide | Semaglutide .68 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-8027 |