Prescription drug · ANDA
Glimepiride NDC 0615-8333
Glimepiride 2 mg/1 · Tablet · Oral · NCS HealthCare of KY, Inc dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8333-39 | 00615833339 | 30 TABLET in 1 BLISTER PACK (0615-8333-39)Marketed from Apr 13, 2020 |
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)
- Glimepiride
- Generic name (nonproprietary)
- glimepiride
- Active ingredients
- Glimepiride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091220
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 0615-8333_18f8ad9b-20d5-47ea-ad3a-9b2a7e3a4dd8SPL ID 18f8ad9b-20d5-47ea-ad3a-9b2a7e3a4dd8SPL set ID 669a67c2-2f97-4b7e-8bba-83a015e0fa94RxCUI 199245, 199246, 199247UNII 6KY687524K
- Pharmacologic class
- Sulfonylurea
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400615833339followed by a unit qualifier and the quantityPackage 00615-8333-39. 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)
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1) ] . Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ). Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091220
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 |
|---|---|---|---|---|
| Glimepiride 3 mgglimepiride | Glimepiride 3 mg/1 | TabletOral | Lifsa Drugs LLC | 72336-641 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1886 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1885 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | BluePoint Laboratories | 68001-585 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | BluePoint Laboratories | 68001-584 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | BluePoint Laboratories | 68001-586 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Micro Labs Limited | 42571-103 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Micro Labs Limited | 42571-100 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Micro Labs Limited | 42571-101 |
| Glimepiride | Glimepiride 3 mg/1 | TabletOral | Micro Labs Limited | 42571-102 |
| Glimepiride | Glimepiride 6 mg/1 | TabletOral | Micro Labs Limited | 42571-104 |
| Glimepiride | Glimepiride 8 mg/1 | TabletOral | Micro Labs Limited | 42571-105 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8332 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8334 |