Prescription drug · ANDA
Glyburide NDC 62135-583
Glyburide 1.25 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-583-30 | 6213505833062135058330 | 30 TABLET in 1 BOTTLE (62135-583-30)Marketed from May 9, 2023 |
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 — 1.25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090937
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 62135-583_458a6ce1-673d-85c7-e063-6294a90a3577SPL ID 458a6ce1-673d-85c7-e063-6294a90a3577SPL set ID 7e661288-2d24-4403-86a1-754afa1d04ffRxCUI 197737, 310534, 310537UNII SX6K58TVWCUPC 0362135585907, 0362135584306, 0362135583309
- 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
N462135058330followed by a unit qualifier and the quantityPackage 62135-0583-30. 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 is 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 62135-583
- What is NDC 62135-583?
- 62135-583 is the product NDC for Glyburide, Glyburide 1.25 mg/1 tablet, listed with the FDA by Chartwell RX, 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?
- Chartwell RX, LLC, NDC labeler code 62135. 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 090937
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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-056 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-057 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-058 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-0495 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5776 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-492 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-659 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-584 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-585 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Proficient Rx LP | 63187-659 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Proficient Rx LP | 63187-667 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-103 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4695 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5030 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5215 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5217 |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0069 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0150 |