Prescription drug · ANDA
Glyburide NDC 71209-011
Glyburide 5 mg/1 · Tablet · Oral · Cadila Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71209-011-05 | 71209001105 | 100 TABLET in 1 BOTTLE (71209-011-05)Marketed from Apr 26, 2014 | |
| 71209-011-10 | 71209001110 | 500 TABLET in 1 BOTTLE (71209-011-10)Marketed from Aug 20, 2019 | |
| 71209-011-11 | 71209001111 | 1000 TABLET in 1 BOTTLE (71209-011-11)Marketed from Apr 26, 2014 |
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
- 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 71209-011_54461b9f-3232-47ce-9e73-a26ab1e44702SPL ID 54461b9f-3232-47ce-9e73-a26ab1e44702SPL set ID ea7a055b-64f0-46bf-aa8e-4a2ef5c3c035RxCUI 197737, 310534, 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
N471209001105followed by a unit qualifier and the quantityPackage 71209-0011-05. 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 | REMEDYREPACK INC. | 70518-4035 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3452 |
| 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 |