Prescription drug · ANDA
Glipizide NDC 43353-207
Glipizide 5 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-207-45 | 43353020745 | 45 TABLET in 1 BOTTLE, PLASTIC (43353-207-45)Marketed from Aug 8, 2016 | |
| 43353-207-60 | 43353020760 | 90 TABLET in 1 BOTTLE, PLASTIC (43353-207-60)Marketed from Aug 8, 2016 | |
| 43353-207-80 | 43353020780 | 180 TABLET in 1 BOTTLE, PLASTIC (43353-207-80)Marketed from Aug 8, 2016 | |
| 43353-207-94 | 43353020794 | 360 TABLET in 1 BOTTLE, PLASTIC (43353-207-94)Marketed from Jan 13, 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
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074223
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 43353-207_c6784fa1-f4f6-403b-bab4-2e681cf226ebSPL ID c6784fa1-f4f6-403b-bab4-2e681cf226ebSPL set ID d6c016f7-bf93-4322-a179-d4798234b381RxCUI 310490UNII 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
N443353020745followed by a unit qualifier and the quantityPackage 43353-0207-45. 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)
INDICATIONS AND USAGE Glipizide tablets are 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 074223
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 | TabletOral | A-S Medication Solutions | 50090-6996 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-0460 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7908 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8512 |
| Glipizide | Glipizide 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc.. | 68788-8138 |
| Glipizide | Glipizide 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4643 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8407 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6473 |
| Glipizide | Glipizide 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8408 |
| Glipizide | Glipizide 10 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-0461 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1398 |
| Glipizide | Glipizide 10 mg/1 | TabletOral | Proficient Rx LP | 63187-811 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-806 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4085 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4939 |
| Glipizide | Glipizide 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-810 |
| Glipizide | Glipizide 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4124 |