Prescription drug · ANDA
Glyburide NDC 68071-4695
Glyburide 5 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4695-3 | 68071469503 | 30 TABLET in 1 BOTTLE (68071-4695-3)Marketed from Jan 7, 2019 | |
| 68071-4695-6 | 68071469506 | 60 TABLET in 1 BOTTLE (68071-4695-6)Marketed from Jan 7, 2019 | |
| 68071-4695-9 | 68071469509 | 90 TABLET in 1 BOTTLE (68071-4695-9)Marketed from Jan 7, 2019 |
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)
- Glyburide
- Generic name (nonproprietary)
- glyburide
- Active ingredients
- Glyburide — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090937
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 68071-4695_2d7d4e63-7233-107c-e063-6394a90a72d1SPL ID 2d7d4e63-7233-107c-e063-6394a90a72d1SPL set ID 7ee41cd3-461f-3408-e053-2991aa0a863dRxCUI 310537UNII SX6K58TVWCUPC 0368071469561
- 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
N468071469503followed by a unit qualifier and the quantityPackage 68071-4695-03. 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 Glyburide tablets, USP is 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 090937
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 | Glyburide 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5776 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-103 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5030 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-0495 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Proficient Rx LP | 63187-659 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-492 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Proficient Rx LP | 63187-667 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5215 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5217 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-584 |
| Glyburide | Glyburide 1.25 mg/1 | TabletOral | Chartwell RX, LLC | 62135-583 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-659 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-585 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0069 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-057 |
| Glyburide | Glyburide 1.25 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-056 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-058 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0150 |