Prescription drug · BLA
Lantus (Insulin glargine) NDC 50090-0876
Insulin glargine 100 [iU]/mL · Injection, Solution · Subcutaneous · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-0876-0 | 5009008760050090087600 | 10 mL in 1 VIAL, GLASS (50090-0876-0)Marketed from Nov 28, 2014 |
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)
- Lantus
- Generic name (nonproprietary)
- insulin glargine
- Active ingredients
- Insulin glargine — 100 [iU]/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 021081
- Marketing start
- Listing expires
- Other FDA classes
- Insulin (Chemical structure)
- Identifiers
- Product ID 50090-0876_36965dca-e4e9-465f-a209-bb5f76739989SPL ID 36965dca-e4e9-465f-a209-bb5f76739989SPL set ID ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99RxCUI 285018, 311041UNII 2ZM8CX04RZ
- Pharmacologic class
- Insulin Analog
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- 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
N450090087600followed by a unit qualifier and the quantityPackage 50090-0876-00. 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 .
Indications (excerpt from the label)
LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. ( 1 ) Limitations of Use LANTUS is not recommended for the treatment of diabetic ketoacidosis.
Excerpt only. Read the full label for complete information.
About NDC 50090-0876
- What is NDC 50090-0876?
- 50090-0876 is the product NDC for Lantus (insulin glargine), Insulin glargine 100 [iU]/mL injection, solution, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lantus (Insulin glargine).
- What is the active ingredient?
- Insulin glargine.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lantus?
- 1 other product NDC are listed under this name. See all Lantus NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lantus products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lantusinsulin glargine | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | sanofi-aventis U.S. LLC | 0088-2220 | 00088-2220-3300088-2220-34 |
Other NDCs under BLA 021081
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 |
|---|---|---|---|---|
| Lantusinsulin glargine | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | sanofi-aventis U.S. LLC | 0088-2220 |
| Lantus Solostarinsulin glargine | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | sanofi-aventis U.S. LLC | 0088-2219 |
| Lantus Solostarinsulin glargine | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-1398 |
| Lantus Solostarinsulin glargine | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-4068 |