Prescription drug · ANDA
Glimepiride NDC 50090-7187
Glimepiride 1 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7187-0 | 50090718700 | 30 TABLET in 1 BOTTLE (50090-7187-0)Marketed from Jul 1, 2024 | |
| 50090-7187-1 | 50090718701 | 100 TABLET in 1 BOTTLE (50090-7187-1)Marketed from Jul 1, 2024 | |
| 50090-7187-2 | 50090718702 | 90 TABLET in 1 BOTTLE (50090-7187-2)Marketed from Jul 1, 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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- 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 50090-7187_b18bab5f-8b2c-4685-8c0e-aa6486d67a08SPL ID b18bab5f-8b2c-4685-8c0e-aa6486d67a08SPL set ID 49bf2d48-efa8-487b-b861-0124c3a4c951RxCUI 199245UNII 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
N450090718700followed by a unit qualifier and the quantityPackage 50090-7187-00. 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 | Bryant Ranch Prepack | 71335-2367 |
| 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 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 |