Prescription drug · ANDA
Glipizide NDC 50090-6848
Glipizide 10 mg/1 · Tablet, Extended release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6848-0 | 50090684800 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6848-0)Marketed from Nov 29, 2023 | |
| 50090-6848-1 | 50090684801 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6848-1)Marketed from Nov 29, 2023 | |
| 50090-6848-2 | 50090684802 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6848-2)Marketed from Nov 29, 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)
- Glipizide
- Generic name (nonproprietary)
- glipizide
- Active ingredients
- Glipizide — 10 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203499
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 50090-6848_4edee9b0-23a0-4e64-a8c1-3dd89d5674cdSPL ID 4edee9b0-23a0-4e64-a8c1-3dd89d5674cdSPL set ID 5014a2d7-e0d3-4e84-9a3e-c90b398b8c6cRxCUI 315107UNII X7WDT95N5C
- 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
N450090684800followed by a unit qualifier and the quantityPackage 50090-6848-00. 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)
Glipizide extended-release tablets is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1.1 Limitations of Use Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203499
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 |
|---|---|---|---|---|
| Glipizide | Glipizide 2.5 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3645 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3896 |
| Glipizide | Glipizide 2.5 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC. | 16714-894 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC. | 16714-895 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC. | 16714-896 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6849 |