Prescription drug · BLA
Semglee (Insulin glargine-yfgn) NDC 83257-012
Insulin glargine 100 [iU]/mL · Injection, Solution · Subcutaneous · Biocon Biologics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83257-012-31 | 8325700123183257001231 | 1 SYRINGE in 1 CARTON (83257-012-31) / 3 mL in 1 SYRINGEMarketed from Jul 28, 2023 | |
| 83257-012-33 | 8325700123383257001233 | 5 SYRINGE in 1 CARTON (83257-012-33) / 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)
- Semglee
- Generic name (nonproprietary)
- insulin glargine-yfgn
- Active ingredients
- Insulin glargine — 100 [iU]/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Biocon Biologics Inc.NDC labeler code 83257
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761201
- Marketing start
- Marketing end
- Other FDA classes
- Insulin (Chemical structure)
- Identifiers
- Product ID 83257-012_3b749417-8933-850b-1373-990e7ee8a312SPL ID 3b749417-8933-850b-1373-990e7ee8a312SPL set ID 8cf5544f-87d6-468b-f6ae-898b1fdb5d80RxCUI 2563971, 2563973, 2563976, 2563977UNII 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
N483257001231followed by a unit qualifier and the quantityPackage 83257-0012-31. 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)
SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use SEMGLEE is not recommended for the treatment of diabetic ketoacidosis. SEMGLEE 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 83257-012
- What is NDC 83257-012?
- 83257-012 is the product NDC for Semglee (insulin glargine-yfgn), Insulin glargine 100 [iU]/mL injection, solution, listed with the FDA by Biocon Biologics Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Semglee (Insulin glargine-yfgn).
- What is the active ingredient?
- Insulin glargine.
- Who is the labeler?
- Biocon Biologics Inc., NDC labeler code 83257. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Semglee?
- 1 other product NDC are listed under this name. See all Semglee NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Semglee products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Semgleeinsulin glargine-yfgn | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | Biocon Biologics Inc. | 83257-011 | 83257-0011-11 |
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 |
|---|---|---|---|---|
| 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 |
| 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 | Biocon Biologics Inc. | 83257-015 |
| Semgleeinsulin glargine-yfgn | Insulin glargine 100 [iU]/mL | Injection, SolutionSubcutaneous | Biocon Biologics Inc. | 83257-011 |