Prescription drug · ANDA
glyburide-metformin hydrochloride NDC 23155-235
Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 · Tablet · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-235-01 | 23155023501 | 100 TABLET in 1 BOTTLE (23155-235-01)Marketed from May 1, 2024 | |
| 23155-235-05 | 23155023505 | 500 TABLET in 1 BOTTLE (23155-235-05)Marketed from May 1, 2024 | |
| 23155-235-10 | 23155023510 | 1000 TABLET in 1 BOTTLE (23155-235-10)Marketed from May 1, 2024 |
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)
- glyburide-metformin hydrochloride
- Generic name (nonproprietary)
- glyburide-metformin hydrochloride
- Active ingredients
- Glyburide — 5 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079009
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 23155-235_6a256976-cf1a-421b-86cb-452fddc75294SPL ID 6a256976-cf1a-421b-86cb-452fddc75294SPL set ID b38213bb-d663-4c95-a1b2-96c23ee5be09RxCUI 861743, 861748, 861753UNII 786Z46389E, SX6K58TVWCUPC 0323155234015, 0323155235012, 0323155233018
- 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
N423155023501followed by a unit qualifier and the quantityPackage 23155-0235-01. 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)
Glyburide and metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079009
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 |
|---|---|---|---|---|
| glyburide-metformin hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8791 |
| glyburide-metformin hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2694 |
| glyburide-metformin hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3950 |
| glyburide-metformin hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2508 |
| glyburide-metformin hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7514 |
| glyburide-metformin hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7814 |
| glyburide-metformin hydrochloride | Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-233 |
| glyburide-metformin hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-234 |