Prescription drug · ANDA
Glimepiride NDC 68788-4191
Glimepiride 4 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4191-3 | 68788419103 | 30 TABLET in 1 BOTTLE (68788-4191-3)Marketed from Sep 24, 2026 | |
| 68788-4191-6 | 68788419106 | 60 TABLET in 1 BOTTLE (68788-4191-6)Marketed from Sep 24, 2026 | |
| 68788-4191-9 | 68788419109 | 90 TABLET in 1 BOTTLE (68788-4191-9)Marketed from Sep 24, 2026 |
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 — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- 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 68788-4191_aa533cde-4b32-450e-b080-127351524678SPL ID aa533cde-4b32-450e-b080-127351524678
- 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
N468788419103followed by a unit qualifier and the quantityPackage 68788-4191-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68788-4191
- What is NDC 68788-4191?
- 68788-4191 is the product NDC for Glimepiride, Glimepiride 4 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 package NDCs, 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2561 | 71335-2561-0171335-2561-0271335-2561-03+2 more |
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 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4485 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4486 |
| 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 | Coupler LLC | 67046-1608 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-214 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-215 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-216 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-7246 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-7247 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Direct_rx | 72189-585 |