Prescription drug · ANDA
Felodipine (Felodipine extended-release tablets) NDC 69117-0030
Felodipine 10 mg/1 · Tablet, Extended release · Oral · Yiling Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69117-0030-1 | 6911700300169117003001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69117-0030-1)Marketed from Aug 1, 2019 | |
| 69117-0030-2 | 6911700300269117003002 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69117-0030-2)Marketed from Aug 1, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 extended-release tablets
- Active ingredients
- Felodipine — 10 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Yiling Pharmaceutical Inc.NDC labeler code 69117
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210847
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 69117-0030_47236bb3-7d75-0c2a-e063-6394a90a7ac7SPL ID 47236bb3-7d75-0c2a-e063-6394a90a7ac7SPL set ID 7990a581-3e0f-5d8c-e053-2991aa0aa6a7RxCUI 402695, 402696, 402698UNII OL961R6O2CUPC 0369117003022, 0369117003015, 0369117002827, 0369117002919, 0369117002810, 0369117002926
- 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
N469117003001followed by a unit qualifier and the quantityPackage 69117-0030-01. 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 69117-0030
- What is NDC 69117-0030?
- 69117-0030 is the product NDC for Felodipine (felodipine extended-release tablets), Felodipine 10 mg/1 tablet, extended release, listed with the FDA by Yiling Pharmaceutical Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Felodipine (Felodipine Extended-release Tablets).
- What is the active ingredient?
- Felodipine.
- Who is the labeler?
- Yiling Pharmaceutical Inc., NDC labeler code 69117. 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 210847
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 | Chartwell RX, LLC | 62135-646 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-647 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-648 |
| Felodipinefelodipine extended-release tablets | Felodipine 2.5 mg/1 | Tablet, Extended releaseOral | Yiling Pharmaceutical Inc. | 69117-0028 |
| Felodipinefelodipine extended-release tablets | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Yiling Pharmaceutical Inc. | 69117-0029 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-264 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-265 |
| Felopdipinefelodipine | Felodipine 10 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7206 |
| Felopdipinefelodipine | Felodipine 10 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-266 |