Prescription drug · ANDA
Glipizide and Metformin Hydrochloride NDC 42291-306
Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-306-01 | 42291030601 | 100 TABLET, FILM COATED in 1 BOTTLE (42291-306-01)Marketed from Jul 8, 2013 |
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 and Metformin Hydrochloride
- Generic name (nonproprietary)
- glipizide and metformin hydrochloride
- Active ingredients
- Glipizide — 5 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077270
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 42291-306_4122e328-9fc7-2590-e063-6394a90a37bdSPL ID 4122e328-9fc7-2590-e063-6394a90a37bdSPL set ID 13be49d2-0ce9-a78a-e557-ded85ddc808fRxCUI 861736, 861740UNII 786Z46389E, X7WDT95N5CUPC 0342291305014, 0342291306011
- Pharmacologic class
- Biguanide; 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
N442291030601followed by a unit qualifier and the quantityPackage 42291-0306-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Glipizide and metformin hydrochloride tablets USP 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 077270
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 and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-305 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7455 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7456 |
| Glipizide and Metformin Hydrochloride | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7457 |
| Glipizide and Metformin Hydrochloride | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0373 |