Prescription drug · ANDA
Glipizide NDC 64980-280
Glipizide 5 mg/1 · Tablet, Film coated, Extended release · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-280-01 | 64980028001 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-280-01)Marketed from Apr 24, 2017 | |
| 64980-280-05 | 64980028005 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-280-05)Marketed from Apr 24, 2017 | |
| 64980-280-10 | 64980028010 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-280-10)Marketed from Apr 24, 2017 |
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)
- Glipizide
- Generic name (nonproprietary)
- glipizide
- Active ingredients
- Glipizide — 5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204720
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 64980-280_efa05b41-c609-4076-adf4-75071cd5f5f0SPL ID efa05b41-c609-4076-adf4-75071cd5f5f0SPL set ID 0ffe361a-c99b-4f68-a7e2-a67a71c0c496RxCUI 310489, 314006, 315107UNII X7WDT95N5CUPC 0364980279031, 0364980281010, 0364980280013
- 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
N464980028001followed by a unit qualifier and the quantityPackage 64980-0280-01. 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 .
Indications (excerpt from the label)
Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide extended-release tablet 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 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 204720
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 10 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-1848 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-7856 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-5806 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-966 |
| Glipizide | Glipizide 2.5 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8487 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1031 |
| Glipizide | Glipizide 2.5 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1042 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-1063 |
| Glipizide | Glipizide 2.5 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-2308 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1130 |
| Glipizide | Glipizide 2.5 mg/1 | Tablet, Film coated, Extended releaseOral | Rising Pharma Holdings, Inc. | 64980-279 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Film coated, Extended releaseOral | Rising Pharma Holdings, Inc. | 64980-281 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-337 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-5040 |