Prescription drug · BLA
Lantus Solostar (insulin glargine) NDC 0088-2219
Insulin glargine 100 [iU]/mL · Injection, Solution · Subcutaneous · sanofi-aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0088-2219-00 | 00088221900 | 1 SYRINGE in 1 CARTON (0088-2219-00) / 3 mL in 1 SYRINGEMarketed from Sep 23, 2009 · Sample package | |
| 0088-2219-05 | 00088221905 | 5 SYRINGE in 1 CARTON (0088-2219-05) / 3 mL in 1 SYRINGE (0088-2219-01)Marketed from Sep 23, 2009 |
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)
- Lantus Solostar
- Generic name (nonproprietary)
- insulin glargine
- Active ingredients
- Insulin glargine — 100 [iU]/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- sanofi-aventis U.S. LLC
- 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 0088-2219_4e220385-b760-4a64-a1ca-84bd2bebe448SPL ID 4e220385-b760-4a64-a1ca-84bd2bebe448SPL set ID d5e07a0c-7e14-4756-9152-9fea485d654aRxCUI 285018, 311041, 847230, 847232UNII 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
N400088221900followed by a unit qualifier and the quantityPackage 00088-2219-00. 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.
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 | A-S Medication Solutions | 50090-0876 |
| 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 | A-S Medication Solutions | 50090-1398 |
| Lantus Solostarinsulin glargine | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-4068 |