Prescription drug · ANDA
Glyburide NDC 0093-8342
Glyburide 1.25 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-8342-01 | 00093834201 | 100 TABLET in 1 BOTTLE (0093-8342-01)Marketed from Aug 30, 1995 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 1.25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- 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 0093-8342_f4b5b433-1b6e-4af2-9d16-7194c2da041cSPL ID f4b5b433-1b6e-4af2-9d16-7194c2da041cSPL set ID a56f100f-0f42-4188-81ab-04644b824040RxCUI 197737, 310534, 310537UNII SX6K58TVWCUPC 0300938343010, 0300938344017, 0300938342013
- 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
N400093834201followed by a unit qualifier and the quantityPackage 00093-8342-01. 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 .
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 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6607 |