Prescription drug · ANDA
Glyburide and Metformin Hydrochloride NDC 68788-8341
Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8341-1 | 68788834101 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8341-1)Marketed from Feb 10, 2023 | |
| 68788-8341-3 | 68788834103 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8341-3)Marketed from Feb 10, 2023 | |
| 68788-8341-6 | 68788834106 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8341-6)Marketed from Feb 10, 2023 | |
| 68788-8341-8 | 68788834108 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8341-8)Marketed from Feb 10, 2023 | |
| 68788-8341-9 | 68788834109 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8341-9)Marketed from Feb 10, 2023 |
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)
- Glyburide and Metformin Hydrochloride
- Generic name (nonproprietary)
- glyburide and metformin hydrochloride
- Active ingredients
- Glyburide — 5 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077870
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 68788-8341_d4b1f97c-2926-4712-ad42-eaac3025e6acSPL ID d4b1f97c-2926-4712-ad42-eaac3025e6acSPL set ID c284c146-436b-4eea-9dca-d7d21c82778cRxCUI 861753UNII SX6K58TVWC, 786Z46389E
- Pharmacologic class
- Biguanide; 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
N468788834101followed by a unit qualifier and the quantityPackage 68788-8341-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077870
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 |
|---|---|---|---|---|
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0967 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0360 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2030 |
| Glyburide and Metformin Hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2031 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4718 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-025 |
| Glyburide and Metformin Hydrochloride | Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-023 |
| Glyburide and Metformin Hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-024 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8634 |
| Glyburide and Metformin Hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7180 |
| Glyburide and Metformin Hydrochloride | Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-080 |
| Glyburide and Metformin Hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-081 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-082 |
| Glyburide and Metformin Hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-942 |