Prescription drug · ANDA
Felodipine NDC 0603-3583
Felodipine 10 mg/1 · Tablet, Film coated, Extended release · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0603-3583-21 | 0060335832100603358321 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3583-21)Marketed from Dec 15, 2011 | |
| 0603-3583-28 | 0060335832800603358328 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3583-28)Marketed from Dec 15, 2011 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 0603
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200815
- Marketing start
- Marketing end
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 0603-3583_02151da2-890e-4f84-94c8-6ce767d9ff12SPL ID 02151da2-890e-4f84-94c8-6ce767d9ff12
- 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
N400603358321followed by a unit qualifier and the quantityPackage 00603-3583-21. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0603-3583
- What is NDC 0603-3583?
- 0603-3583 is the product NDC for Felodipine, Felodipine 10 mg/1 tablet, film coated, extended release, listed with the FDA by Par Health USA, LLC. It has 2 package NDCs, 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?
- Par Health USA, LLC, NDC labeler code 0603. 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 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 2.5 mg/1 | Tablet, Extended releaseOral | Par Health USA, LLC | 0603-3581 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Par Health USA, LLC | 0603-3582 |
| 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 | Bryant Ranch Prepack | 63629-2196 |
| 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 |