Prescription drug · ANDA
Felodipine NDC 57237-109
Felodipine 5 mg/1 · Tablet, Film coated, Extended release · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-109-01 | 5723701090157237010901 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-109-01)Marketed from Jan 17, 2013 |
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, Extended release
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 57237
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203417
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 57237-109_9ea82ae9-2d77-4da4-8213-dda2434df9d7SPL ID 9ea82ae9-2d77-4da4-8213-dda2434df9d7SPL set ID f5f56c59-04d5-4c5d-9441-5a93d3bdec82RxCUI 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
N457237010901followed by a unit qualifier and the quantityPackage 57237-0109-01. 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.
About NDC 57237-109
- What is NDC 57237-109?
- 57237-109 is the product NDC for Felodipine, Felodipine 5 mg/1 tablet, film coated, extended release, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Felodipine.
- What is the active ingredient?
- Felodipine.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 57237. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Felodipine?
- 49 other product NDCs are listed under this name. See all Felodipine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Felodipine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-264 | 69367-0264-01 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-265 | 69367-0265-01 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-431 | 61442-0431-0161442-0431-05 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-432 | 61442-0432-0161442-0432-05 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-433 | 61442-0433-0161442-0433-05 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2016 | 63629-2016-01 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2017 | 63629-2017-01 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2018 | 63629-2018-01 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-920 | 71205-0920-0071205-0920-3071205-0920-55+3 more |
| Felodipine | Felodipine 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-921 | 71205-0921-0071205-0921-3071205-0921-55+3 more |
Other NDCs under ANDA 203417
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 10 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-5870 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Film coated, Extended releaseOral | Rising Pharma Holdings, Inc. | 57237-108 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Rising Pharma Holdings, Inc. | 57237-110 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-673 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-674 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1318 |