Prescription drug · ANDA
Glipizide and Metformin HCl NDC 23155-116
Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-116-01 | 23155011601 | 100 TABLET, FILM COATED in 1 BOTTLE (23155-116-01)Marketed from Jun 29, 2010 | |
| 23155-116-10 | 23155011610 | 1000 TABLET, FILM COATED in 1 BOTTLE (23155-116-10)Marketed from Jun 29, 2010 |
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 HCl
- Generic name (nonproprietary)
- glipizide and metformin hcl
- Active ingredients
- Glipizide — 2.5 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078728
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 23155-116_76d38b93-d93e-48eb-9162-8ffd4733a111SPL ID 76d38b93-d93e-48eb-9162-8ffd4733a111SPL set ID 94a7f96e-2ed1-432d-bc6a-5840863816e1RxCUI 861731, 861736, 861740UNII 786Z46389E, X7WDT95N5C
- 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
N423155011601followed by a unit qualifier and the quantityPackage 23155-0116-01. 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 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 078728
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 HCl | Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-115 |
| Glipizide and Metformin HCl | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-117 |
| Glipizide and metformin hcl | Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-731 |
| Glipizide and metformin hcl | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-732 |
| Glipizide and metformin hcl | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-733 |
| Glipizide and Metformin HCl | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-270 |