Prescription drug · ANDA
Glyburide NDC 67046-1620
Glyburide 2.5 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1620-3 | 6704616200367046162003 | 30 TABLET in 1 BLISTER PACK (67046-1620-3)Marketed from Dec 8, 2025 |
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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- 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 67046-1620_4573af53-70f9-b5d7-e063-6294a90af2e0SPL ID 4573af53-70f9-b5d7-e063-6294a90af2e0SPL set ID 4573af7f-3c71-e323-e063-6394a90aa9ebRxCUI 310534UNII 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
N467046162003followed by a unit qualifier and the quantityPackage 67046-1620-03. 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.
About NDC 67046-1620
- What is NDC 67046-1620?
- 67046-1620 is the product NDC for Glyburide, Glyburide 2.5 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?
- Coupler LLC, NDC labeler code 67046. 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 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4035 | 70518-4035-0070518-4035-01 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8508 | 68788-8508-0168788-8508-0368788-8508-06+1 more |
| 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 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 1.25 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-8342 |
| 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 | A-S Medication Solutions | 50090-6607 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Proficient Rx LP | 63187-848 |
| 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 5 mg/1 | TabletOral | Proficient Rx LP | 82804-150 |