Prescription drug · BLA
Apidra SoloStar (insulin glulisine) NDC 0088-2502
Insulin glulisine 100 [iU]/mL · Injection, Solution · Subcutaneous · sanofi-aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0088-2502-01 | 00088250201 | 1 SYRINGE, PLASTIC in 1 CARTON (0088-2502-01) / 3 mL in 1 SYRINGE, PLASTICMarketed from Feb 24, 2009 | |
| 0088-2502-05 | 00088250205 | 5 SYRINGE, PLASTIC in 1 CARTON (0088-2502-05) / 3 mL in 1 SYRINGE, PLASTIC (0088-2502-00)Marketed from Feb 24, 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)
- Apidra SoloStar
- Generic name (nonproprietary)
- insulin glulisine
- Active ingredients
- Insulin glulisine — 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 021629
- Marketing start
- Listing expires
- Other FDA classes
- Insulin (Chemical/Ingredient)
- Identifiers
- Product ID 0088-2502_6be54063-6912-4810-b1c7-dfca969224d8SPL ID 6be54063-6912-4810-b1c7-dfca969224d8SPL set ID e7af6a7a-8046-4fb4-9979-4ec4230b23aaRxCUI 485210, 803194, 847259, 847261UNII 7XIY785AZD
- 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
N400088250201followed by a unit qualifier and the quantityPackage 00088-2502-01. 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)
APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. APIDRA is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 021629
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 |
|---|---|---|---|---|
| Apidrainsulin glulisine | Insulin glulisine 100 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | sanofi-aventis U.S. LLC | 0088-2500 |