Prescription drug · ANDA
Glipizide NDC 59651-781
Glipizide 5 mg/1 · Tablet, Extended release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-781-01 | 5965107810159651078101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-781-01)Marketed from Mar 3, 2023 | |
| 59651-781-05 | 5965107810559651078105 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-781-05)Marketed from Mar 3, 2023 | |
| 59651-781-30 | 5965107813059651078130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-781-30)Marketed from Mar 3, 2023 |
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, Extended release
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206928
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 59651-781_7d29a701-73cf-42ce-9068-b9a5153fdb56SPL ID 7d29a701-73cf-42ce-9068-b9a5153fdb56SPL set ID 84794a52-b717-488c-8533-6425c83d405fRxCUI 310489, 314006, 315107UNII X7WDT95N5CUPC 0359651782309, 0359651781302
- 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
N459651078101followed by a unit qualifier and the quantityPackage 59651-0781-01. 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 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 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.
About NDC 59651-781
- What is NDC 59651-781?
- 59651-781 is the product NDC for Glipizide, Glipizide 5 mg/1 tablet, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glipizide.
- What is the active ingredient?
- Glipizide.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glipizide?
- 135 other product NDCs are listed under this name. See all Glipizide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glipizide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glipizide | Glipizide 5 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-117 | 11788-0117-0111788-0117-0511788-0117-10 |
| Glipizide | Glipizide 10 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-118 | 11788-0118-00 |
| Glipizide | Glipizide 2.5 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-120 | 11788-0120-0111788-0120-0511788-0120-10 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-579 | 72789-0579-3072789-0579-6072789-0579-86+3 more |
| Glipizide | Glipizide 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-580 | 72789-0580-3072789-0580-6072789-0580-86+3 more |
| Glipizide | Glipizide 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4178 | 68788-4178-0168788-4178-0368788-4178-06+2 more |
| Glipizide | Glipizide 10 mg/1 | TabletOral | Coupler LLC | 67046-0367 | 67046-0367-03 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | Coupler LLC | 67046-0236 | 67046-0236-03 |
| Glipizide | Glipizide 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4061 | 68788-4061-0168788-4061-0368788-4061-06+2 more |
| Glipizide | Glipizide 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4017 | 68788-4017-0168788-4017-0368788-4017-06+2 more |
Other NDCs under ANDA 206928
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 5 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6746 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6765 |
| Glipizide | Glipizide 2.5 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-768 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-881 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-793 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-794 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3898 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4128 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2353 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-9742 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2614 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 82868-025 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 82868-035 |