Prescription drug · ANDA
Glimepiride NDC 16571-774
Glimepiride 2 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-774-01 | 16571077401 | 100 TABLET in 1 BOTTLE (16571-774-01)Marketed from Jun 29, 2012 | |
| 16571-774-50 | 16571077450 | 500 TABLET in 1 BOTTLE (16571-774-50)Marketed from Jun 29, 2012 |
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)
- Glimepiride
- Generic name (nonproprietary)
- glimepiride
- Active ingredients
- Glimepiride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202759
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 16571-774_f06a97e3-4349-4df3-87de-4479c1ed69bcSPL ID f06a97e3-4349-4df3-87de-4479c1ed69bcSPL set ID 48ada723-8144-497d-afd6-a8c52a1dd3ffRxCUI 199245, 199246, 199247UNII 6KY687524KUPC 0316571774012, 0316571773015, 0316571775019
- 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
N416571077401followed by a unit qualifier and the quantityPackage 16571-0774-01. 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)
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 202759
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 | Glimepiride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-7628 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-6394 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-6426 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-042 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-800 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Direct_Rx | 72189-485 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-370 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9654 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9655 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-773 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-775 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Proficient Rx LP | 71205-773 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Proficient Rx LP | 71205-779 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-580 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-579 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-581 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-7823 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Proficient Rx LP | 82804-065 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8432 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-6322 |