Prescription drug · ANDA
Glimepiride NDC 72789-370
Glimepiride 2 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-370-30 | 72789037030 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-370-30)Marketed from Jan 16, 2024 |
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
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
- 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 72789-370_4bbf5d4c-4e06-6610-e063-6294a90a0041SPL ID 4bbf5d4c-4e06-6610-e063-6294a90a0041SPL set ID 1450f455-a14a-4f9b-b3aa-dae49ea0c186RxCUI 199246UNII 6KY687524KUPC 0372789370309
- 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
N472789037030followed by a unit qualifier and the quantityPackage 72789-0370-30. 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.
About NDC 72789-370
- What is NDC 72789-370?
- 72789-370 is the product NDC for Glimepiride, Glimepiride 2 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glimepiride.
- What is the active ingredient?
- Glimepiride.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glimepiride?
- 102 other product NDCs are listed under this name. See all Glimepiride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glimepiride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4191 | 68788-4191-0368788-4191-0668788-4191-09 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Coupler LLC | 67046-1608 | 67046-1608-03 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4486 | 70518-4486-00 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4485 | 70518-4485-0070518-4485-0170518-4485-02 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Direct_rx | 72189-585 | 72189-0585-90 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8728 | 68788-8728-0168788-8728-0368788-8728-06+1 more |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-042 | 82868-0042-90 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | BluePoint Laboratories | 68001-584 | 68001-0584-0068001-0584-03 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | BluePoint Laboratories | 68001-585 | 68001-0585-0068001-0585-03 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | BluePoint Laboratories | 68001-586 | 68001-0586-0068001-0586-03 |
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 4 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-581 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Proficient Rx LP | 71205-779 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-579 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-580 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-7823 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8432 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-042 |
| 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 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-6322 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-800 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Proficient Rx LP | 82804-065 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Direct_Rx | 72189-485 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9655 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9654 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-773 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-774 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-775 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Proficient Rx LP | 71205-773 |