Prescription drug · ANDA
Glyburide NDC 0093-8343
Glyburide 2.5 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-8343-01 | 0009383430100093834301 | 100 TABLET in 1 BOTTLE (0093-8343-01)Marketed from Aug 30, 1995 | |
| 0093-8343-05 | 0009383430500093834305 | 500 TABLET in 1 BOTTLE (0093-8343-05)Marketed from Aug 30, 1995 | |
| 0093-8343-10 | 0009383431000093834310 | 1000 TABLET in 1 BOTTLE (0093-8343-10)Marketed from Aug 30, 1995 | |
| 0093-8343-98 | 0009383439800093834398 | 90 TABLET in 1 BOTTLE (0093-8343-98)Marketed from Mar 30, 2010 |
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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- 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 0093-8343_2ef0bcc2-d9f5-406a-863e-b070f0052232SPL ID 2ef0bcc2-d9f5-406a-863e-b070f0052232
- 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
N400093834301followed by a unit qualifier and the quantityPackage 00093-8343-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0093-8343
- What is NDC 0093-8343?
- 0093-8343 is the product NDC for Glyburide, Glyburide 2.5 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, 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?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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 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 |
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 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 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1620 |
| 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 |