Prescription drug · ANDA
Glimepiride NDC 43063-698
Glimepiride 2 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-698-30 | 43063069830 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-698-30)Marketed from Sep 5, 2019 | |
| 43063-698-90 | 43063069890 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-698-90)Marketed from Aug 1, 2016 | |
| 43063-698-93 | 43063069893 | 180 TABLET in 1 BOTTLE, PLASTIC (43063-698-93)Marketed from Aug 1, 2016 |
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)
- Glimepiride
- Generic name (nonproprietary)
- glimepiride
- Active ingredients
- Glimepiride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077911
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 43063-698_2b376d88-25a8-b97f-e063-6394a90adfedSPL ID 2b376d88-25a8-b97f-e063-6394a90adfedSPL set ID 11ae3189-6139-4470-95d5-72abc0f5b0d0RxCUI 199246UNII 6KY687524KUPC 0343063698303
- 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
N443063069830followed by a unit qualifier and the quantityPackage 43063-0698-30. 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)
Glimepiride Tablet 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 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 ). Important Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077911
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 | Carlsbad Technology, Inc. | 61442-115 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Carlsbad Technology, Inc. | 61442-116 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Carlsbad Technology, Inc. | 61442-117 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-946 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-048 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-918 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-919 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-920 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-236 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-697 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-699 |