Prescription drug · ANDA
Glyburide NDC 50090-6607
Glyburide 5 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6607-0 | 50090660700 | 90 TABLET in 1 BOTTLE (50090-6607-0)Marketed from Aug 22, 2023 |
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
- A-S Medication Solutions
- 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 50090-6607_68360104-6b80-4b68-9c54-b4a9b5b701ceSPL ID 68360104-6b80-4b68-9c54-b4a9b5b701ceSPL set ID 922d1080-52c6-41e4-a310-533d8ca18594RxCUI 310537UNII SX6K58TVWC
- 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
N450090660700followed by a unit qualifier and the quantityPackage 50090-6607-00. 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 | Proficient Rx LP | 82804-150 |
| 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 1.25 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-8342 |