Prescription drug · ANDA
Glipizide and Metformin Hydrochloride NDC 50090-2492
Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-2492-0 | 50090249200 | 180 TABLET, FILM COATED in 1 BOTTLE (50090-2492-0)Marketed from Oct 12, 2016 |
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 and Metformin Hydrochloride
- Generic name (nonproprietary)
- glipizide and metformin hydrochloride
- Active ingredients
- Glipizide — 2.5 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078905
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 50090-2492_1e31e5b7-d6ba-401b-a3d5-c27ef03f90c7SPL ID 1e31e5b7-d6ba-401b-a3d5-c27ef03f90c7SPL set ID 4a2d814b-93a1-4487-b789-dbafe9f0ffd3RxCUI 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
N450090249200followed by a unit qualifier and the quantityPackage 50090-2492-00. 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 078905
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 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2556 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-184 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-185 |
| Glipizide and Metformin Hydrochloride | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-186 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-659 |
| Glipizide and Metformin Hydrochloride | Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-660 |
| Glipizide and Metformin Hydrochloride | Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-661 |