Prescription drug · ANDA
Felodipine NDC 68462-235
Felodipine 10 mg/1 · Tablet, Film coated, Extended release · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-235-01 | 68462023501 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-235-01)Marketed from Dec 20, 2010 | |
| 68462-235-10 | 68462023510 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-235-10)Marketed from Dec 20, 2010 | |
| 68462-235-11 | 68462023511 | 10 BLISTER PACK in 1 CARTON (68462-235-11) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 20, 2010 | |
| 68462-235-90 | 68462023590 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-235-90)Marketed from Dec 20, 2010 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090365
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 68462-235_8663994d-841f-427a-93db-b4c9d10bad27SPL ID 8663994d-841f-427a-93db-b4c9d10bad27SPL set ID 2e4298cf-02e9-49c7-9803-887161e1989aRxCUI 402695, 402696, 402698UNII OL961R6O2CUPC 0368462235010, 0368462233016, 0368462234013
- 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
N468462023501followed by a unit qualifier and the quantityPackage 68462-0235-01. 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 tablets 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 achieve blood pressure g…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090365
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, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1486 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Film coated, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-234 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Film coated, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-233 |