Prescription drug · ANDA
Glyburide NDC 68071-3452
Glyburide 5 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3452-3 | 68071345203 | 30 TABLET in 1 BOTTLE (68071-3452-3)Marketed from Jul 6, 2023 | |
| 68071-3452-6 | 68071345206 | 60 TABLET in 1 BOTTLE (68071-3452-6)Marketed from Jan 16, 2026 |
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 203379
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 68071-3452_48860991-6561-7756-e063-6394a90a7d01SPL ID 48860991-6561-7756-e063-6394a90a7d01SPL set ID ffd31d06-6011-34e2-e053-6394a90a437fRxCUI 310537UNII SX6K58TVWCUPC 0368071345230
- 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
N468071345203followed by a unit qualifier and the quantityPackage 68071-3452-03. 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 & USAGE Glyburide 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 203379
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 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7859 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8508 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7408 |
| Glyburide | Glyburide 1.25 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-009 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-010 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-011 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4035 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3504 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2771 |
| Glyburide | Glyburide 1.25 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-038 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6196 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-039 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-040 |