Prescription drug · BLA
Insulin Glargine (insulin glargine-yfgn) NDC 83257-015
Insulin glargine 100 [iU]/mL · Injection, Solution · Subcutaneous · Biocon Biologics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83257-015-31 | 83257001531 | 1 SYRINGE in 1 CARTON (83257-015-31) / 3 mL in 1 SYRINGEMarketed from Jul 28, 2023 | |
| 83257-015-32 | 83257001532 | 5 SYRINGE in 1 CARTON (83257-015-32) / 3 mL in 1 SYRINGEMarketed from Jul 28, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Insulin Glargine
- Generic name (nonproprietary)
- insulin glargine-yfgn
- Active ingredients
- Insulin glargine — 100 [iU]/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Biocon Biologics Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761201
- Marketing start
- Listing expires
- Other FDA classes
- Insulin (Chemical structure)
- Identifiers
- Product ID 83257-015_1788fd3f-09d7-eb86-5e9e-db823fa41a8aSPL ID 1788fd3f-09d7-eb86-5e9e-db823fa41a8aSPL set ID 3ac85ebb-5594-59c8-77fd-df254329d151RxCUI 2563971, 2563976UNII 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
N483257001531followed by a unit qualifier and the quantityPackage 83257-0015-31. 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)
Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis. Insulin Glargine-yfgn 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.
Other NDCs under BLA 761201
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 |
|---|---|---|---|---|
| Semgleeinsulin glargine-yfgn | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | Biocon Biologics Inc. | 83257-011 |
| Semgleeinsulin glargine-yfgn | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | Biocon Biologics Inc. | 83257-012 |
| Insulin Glargineinsulin glargine-yfgn | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | Biocon Biologics Inc. | 83257-014 |
| Insulin Glargineinsulin glargine-yfgn | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | Civica, Inc. | 72572-422 |
| Insulin Glargineinsulin glargine-yfgn | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | Civica, Inc. | 72572-424 |