Prescription drug · ANDA
Glipizide NDC 70518-3645
Glipizide 2.5 mg/1 · Tablet, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3645-1 | 70518364501 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3645-1)Marketed from Jul 15, 2024 |
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 — 2.5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- 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 70518-3645_5904acc8-353c-cdda-e063-6394a90a8bc7SPL ID 5904acc8-353c-cdda-e063-6394a90a8bc7SPL set ID e4831ddb-9680-40cb-a060-4ba77c52d0aaRxCUI 310489UNII 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
N470518364501followed by a unit qualifier and the quantityPackage 70518-3645-01. 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 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 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 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6848 |