Prescription drug · ANDA
Felodipine NDC 0603-3581
Felodipine 2.5 mg/1 · Tablet, Extended release · Oral · Endo USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0603-3581-21 | 00603358121 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3581-21)Marketed from Mar 31, 2009 | |
| 0603-3581-28 | 00603358128 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3581-28)Marketed from Mar 31, 2009 |
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)
- Felodipine
- Generic name (nonproprietary)
- felodipine
- Active ingredients
- Felodipine — 2.5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Endo USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200815
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 0603-3581_ca215c73-f6f1-492c-810c-876e46001086SPL ID ca215c73-f6f1-492c-810c-876e46001086SPL set ID 55637724-8757-11de-8a39-0800200c9a66RxCUI 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
N400603358121followed by a unit qualifier and the quantityPackage 00603-3581-21. 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 200815
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 |
|---|---|---|---|---|
| Felodipine | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-2196 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-2191 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-2195 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Endo USA, Inc. | 0603-3582 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Endo USA, Inc. | 0603-3583 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-1158 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1160 |