Prescription drug · ANDA
Felodipine NDC 61442-432
Felodipine 5 mg/1 · Tablet, Film coated · Oral · Carlsbad Technology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61442-432-01 | 61442043201 | 100 TABLET, FILM COATED in 1 BOTTLE (61442-432-01)Marketed from Oct 12, 2020 | |
| 61442-432-05 | 61442043205 | 500 TABLET, FILM COATED in 1 BOTTLE (61442-432-05)Marketed from Oct 12, 2020 |
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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Carlsbad Technology, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204800
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 61442-432_2e6e562c-bff2-1d2f-e063-6394a90a5001SPL ID 2e6e562c-bff2-1d2f-e063-6394a90a5001SPL set ID 7bd4fa00-f0d8-4aea-9c24-a799b05e60e1RxCUI 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
N461442043201followed by a unit qualifier and the quantityPackage 61442-0432-01. 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 nonfatal 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 one drug to ac…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204800
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 coatedOral | Golden State Medical Supply, Inc. | 51407-088 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-089 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-922 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-920 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-921 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-431 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-433 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2175 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2016 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2017 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2018 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1743 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1742 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1744 |