Prescription drug · ANDA
Glyburide NDC 68788-8508
Glyburide 5 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8508-1 | 6878885080168788850801 | 100 TABLET in 1 BOTTLE (68788-8508-1)Marketed from Aug 16, 2023 | |
| 68788-8508-3 | 6878885080368788850803 | 30 TABLET in 1 BOTTLE (68788-8508-3)Marketed from Aug 16, 2023 | |
| 68788-8508-6 | 6878885080668788850806 | 60 TABLET in 1 BOTTLE (68788-8508-6)Marketed from Aug 16, 2023 | |
| 68788-8508-9 | 6878885080968788850809 | 90 TABLET in 1 BOTTLE (68788-8508-9)Marketed from Aug 16, 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
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- 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 68788-8508_a4d8afca-575f-43ba-9a84-30c00a07a015SPL ID a4d8afca-575f-43ba-9a84-30c00a07a015SPL set ID cf21c8c0-7247-4d5b-97f8-ae4016144642RxCUI 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
N468788850801followed by a unit qualifier and the quantityPackage 68788-8508-01. 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 & 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.
About NDC 68788-8508
- What is NDC 68788-8508?
- 68788-8508 is the product NDC for Glyburide, Glyburide 5 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glyburide.
- What is the active ingredient?
- Glyburide.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glyburide?
- 51 other product NDCs are listed under this name. See all Glyburide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glyburide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glyburide | Glyburide 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4073 | 68788-4073-0168788-4073-0368788-4073-06+1 more |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1620 | 67046-1620-03 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4035 | 70518-4035-0070518-4035-01 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3504 | 70518-3504-0070518-3504-01 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6196 | 50090-6196-0050090-6196-0150090-6196-02+2 more |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7408 | 50090-7408-0050090-7408-02 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7859 | 50090-7859-00 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3452 | 68071-3452-0368071-3452-06 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2771 | 71335-2771-0171335-2771-0271335-2771-03+3 more |
| Glyburide | Glyburide 1.25 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-038 | 72241-0038-0572241-0038-11 |
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 | 50090-6196 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7408 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7859 |
| 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 | REMEDYREPACK INC. | 70518-4035 |
| 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 | Bryant Ranch Prepack | 71335-2771 |
| Glyburide | Glyburide 1.25 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-038 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-039 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-040 |