Prescription drug · ANDA
Felodipine NDC 69367-264
Felodipine 2.5 mg/1 · Tablet, Extended release · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-264-01 | 69367026401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-264-01)Marketed from Mar 31, 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)
- Felodipine
- Generic name (nonproprietary)
- felodipine
- Active ingredients
- Felodipine — 2.5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210847
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 69367-264_51791555-1064-4991-b58c-3a37ce596d60SPL ID 51791555-1064-4991-b58c-3a37ce596d60SPL set ID a6560584-e39f-47b3-84db-95da1f90fd40RxCUI 402695, 402696, 402698UNII OL961R6O2C
- Pharmacologic class
- Dihydropyridine Calcium Channel Blocker
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
N469367026401followed by a unit qualifier and the quantityPackage 69367-0264-01. 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)
INDICATIONS AND USAGE Felodipine Extended-release Tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to ac…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210847
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 |
|---|---|---|---|---|
| Felodipinefelodipine extended-release tablets | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Yiling Pharmaceutical Inc. | 69117-0029 |
| Felodipinefelodipine extended-release tablets | Felodipine 2.5 mg/1 | Tablet, Extended releaseOral | Yiling Pharmaceutical Inc. | 69117-0028 |
| Felodipinefelodipine extended-release tablets | Felodipine 10 mg/1 | Tablet, Extended releaseOral | Yiling Pharmaceutical Inc. | 69117-0030 |
| Felopdipinefelodipine | Felodipine 10 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7206 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-646 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-647 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-648 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-265 |
| Felopdipinefelodipine | Felodipine 10 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-266 |