Prescription drug · ANDA
Glimepiride NDC 63629-3043
Glimepiride 2 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-3043-1 | 6362930430163629304301 | 30 TABLET in 1 BOTTLE (63629-3043-1)Marketed from Jun 23, 2010 | |
| 63629-3043-2 | 6362930430263629304302 | 60 TABLET in 1 BOTTLE (63629-3043-2)Marketed from Jun 23, 2010 | |
| 63629-3043-3 | 6362930430363629304303 | 90 TABLET in 1 BOTTLE (63629-3043-3)Marketed from Jun 7, 2007 | |
| 63629-3043-4 | 6362930430463629304304 | 100 TABLET in 1 BOTTLE (63629-3043-4)Marketed from Jun 7, 2007 | |
| 63629-3043-5 | 6362930430563629304305 | 180 TABLET in 1 BOTTLE (63629-3043-5)Marketed from Jun 23, 2010 |
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)
- Glimepiride
- Generic name (nonproprietary)
- glimepiride
- Active ingredients
- Glimepiride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077091
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 63629-3043_d877f389-167f-42c4-a9c2-adc90a7cad20SPL ID d877f389-167f-42c4-a9c2-adc90a7cad20SPL set ID ebb9f080-b11d-5d18-36f0-627107e7fbcdRxCUI 199246UNII 6KY687524K
- 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
N463629304301followed by a unit qualifier and the quantityPackage 63629-3043-01. 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)
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1 ) ]. Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. Glimepiride tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ). Limitations of Use : Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 63629-3043
- What is NDC 63629-3043?
- 63629-3043 is the product NDC for Glimepiride, Glimepiride 2 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glimepiride.
- What is the active ingredient?
- Glimepiride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glimepiride?
- 101 other product NDCs are listed under this name. See all Glimepiride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glimepiride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4191 | 68788-4191-0368788-4191-0668788-4191-09 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Coupler LLC | 67046-1608 | 67046-1608-03 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4486 | 70518-4486-00 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4485 | 70518-4485-0070518-4485-0170518-4485-02 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Direct_rx | 72189-585 | 72189-0585-90 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8728 | 68788-8728-0168788-8728-0368788-8728-06+1 more |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-042 | 82868-0042-90 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | BluePoint Laboratories | 68001-584 | 68001-0584-0068001-0584-03 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | BluePoint Laboratories | 68001-585 | 68001-0585-0068001-0585-03 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | BluePoint Laboratories | 68001-586 | 68001-0586-0068001-0586-03 |
Other NDCs under ANDA 077091
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 |
|---|---|---|---|---|
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-121 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-122 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-1006 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-6415 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-6852 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-6910 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | AvPAK | 50268-358 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | AvPAK | 50268-359 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | AvPAK | 50268-360 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-489 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-565 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-320 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-321 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-322 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-8175 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2228 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2385 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | American Health Packaging | 68084-326 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | American Health Packaging | 68084-327 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | American Health Packaging | 68084-788 |
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