Prescription drug · NDA
Ozempic (semaglutide) NDC 50090-5949
Semaglutide 1.34 mg/mL · Injection, Solution · Subcutaneous · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5949-0 | 50090594900 | 1 SYRINGE, PLASTIC in 1 CARTON (50090-5949-0) / 3 mL in 1 SYRINGE, PLASTICMarketed from Apr 1, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 1.34 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- A-S Medication Solutions
- 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 50090-5949_a5c23c93-1c61-4768-b7f2-1e430cd21a8dSPL ID a5c23c93-1c61-4768-b7f2-1e430cd21a8dSPL set ID 979e4df4-0597-48ea-b51c-0f699fa6d166RxCUI 2398841, 2398842UNII 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 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
N450090594900followed by a unit qualifier and the quantityPackage 50090-5949-00. 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)
OZEMPIC is 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 events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. Limitations of Use • OZEMPIC has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis [see Warnings and Precautions ( 5.2 )] . • OZEMPIC is not indicated for use in patients with type 1 diabetes mellitus. OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist …
Excerpt only. Read the full label for complete information.
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 2.68 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-6051 |
| Ozempicsemaglutide | Semaglutide .68 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-8027 |
| Ozempicsemaglutide | Semaglutide 1.34 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharmaceutical Industries, LP | 0169-4130 |
| Ozempicsemaglutide | Semaglutide .68 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk Pharmaceutical Industries, LP | 0169-4181 |