Prescription drug · ANDA
Glimepiride NDC 71335-2367
Glimepiride 2 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2367-1 | 71335236701 | 30 TABLET in 1 BOTTLE (71335-2367-1)Marketed from Apr 30, 2024 | |
| 71335-2367-2 | 71335236702 | 60 TABLET in 1 BOTTLE (71335-2367-2)Marketed from Apr 30, 2024 | |
| 71335-2367-3 | 71335236703 | 90 TABLET in 1 BOTTLE (71335-2367-3)Marketed from Apr 30, 2024 | |
| 71335-2367-4 | 71335236704 | 100 TABLET in 1 BOTTLE (71335-2367-4)Marketed from Apr 30, 2024 | |
| 71335-2367-5 | 71335236705 | 180 TABLET in 1 BOTTLE (71335-2367-5)Marketed from Apr 30, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202112
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 71335-2367_f95e9e3a-73c3-4a11-a0ec-be1281cdcdd2SPL ID f95e9e3a-73c3-4a11-a0ec-be1281cdcdd2SPL set ID cdeda274-955b-413d-b2d4-b14d94f7d20cRxCUI 199246UNII 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
N471335236701followed by a unit qualifier and the quantityPackage 71335-2367-01. 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 tablets 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 202112
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 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2561 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8728 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4486 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4485 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3639 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-7406 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-7407 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2409 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-7187 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-845 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-215 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Coupler LLC | 67046-1608 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-214 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-216 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-7247 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-7246 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Direct_rx | 72189-585 |