Prescription drug · BLA
Rezvoglar KwikPen (Insulin glargine-aglr) NDC 0002-8980
Insulin glargine 100 [iU]/mL · Injection, Solution · Subcutaneous · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-8980-05 | 0000289800500002898005 | 5 SYRINGE in 1 CARTON (0002-8980-05) / 3 mL in 1 SYRINGE (0002-8980-01)Marketed from Dec 17, 2021 |
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)
- Rezvoglar KwikPenSuffix: KwikPen
- Generic name (nonproprietary)
- insulin glargine-aglr
- Active ingredients
- Insulin glargine — 100 [iU]/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Eli Lilly and CompanyNDC labeler code 0002
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761215
- Marketing start
- Listing expires
- Other FDA classes
- Insulin (Chemical structure)
- Identifiers
- Product ID 0002-8980_a9e95b4c-e280-4bef-a3dd-4907bfad6b4dSPL ID a9e95b4c-e280-4bef-a3dd-4907bfad6b4dSPL set ID f6af8706-2058-4fe1-99c8-43684c20bfa2RxCUI 2589008, 2589014UNII 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
N400002898005followed by a unit qualifier and the quantityPackage 00002-8980-05. 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)
REZVOGLAR™ is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use REZVOGLAR is not recommended for the treatment of diabetic ketoacidosis. REZVOGLAR™ 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 )
Excerpt only. Read the full label for complete information.
About NDC 0002-8980
- What is NDC 0002-8980?
- 0002-8980 is the product NDC for Rezvoglar KwikPen (insulin glargine-aglr), Insulin glargine 100 [iU]/mL injection, solution, listed with the FDA by Eli Lilly and Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rezvoglar KwikPen (Insulin glargine-aglr).
- What is the active ingredient?
- Insulin glargine.
- Who is the labeler?
- Eli Lilly and Company, NDC labeler code 0002. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rezvoglar KwikPen?
- 1 other product NDC are listed under this name. See all Rezvoglar KwikPen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rezvoglar KwikPen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rezvoglar Kwikpeninsulin glargine-aglr | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-6439 | 50090-6439-00 |
Other NDCs under BLA 761215
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 |
|---|---|---|---|---|
| Rezvoglar Kwikpeninsulin glargine-aglr | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-6439 |