Prescription drug · ANDA
Glyburide NDC 82804-150
Glyburide 5 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-150-00 | 82804015000 | 100 TABLET in 1 BOTTLE (82804-150-00)Marketed from Sep 24, 2024 | |
| 82804-150-30 | 82804015030 | 30 TABLET in 1 BOTTLE (82804-150-30)Marketed from Jul 18, 2025 |
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
- Generic name (nonproprietary)
- glyburide
- Active ingredients
- Glyburide — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074388
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 82804-150_7378c94f-e2fc-4990-977b-9087a3789e91SPL ID 7378c94f-e2fc-4990-977b-9087a3789e91SPL set ID 6f65131c-90df-45ab-95fb-c36f411c6fbeRxCUI 310537UNII SX6K58TVWCUPC 0382804150007
- 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
N482804015000followed by a unit qualifier and the quantityPackage 82804-0150-00. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Glyburide tablets USP 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 074388
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 | Teva Pharmaceuticals USA, Inc. | 0093-8343 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-8344 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3677 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3702 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4073 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Proficient Rx LP | 63187-848 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1620 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6607 |
| Glyburide | Glyburide 1.25 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-8342 |