Prescription drug · ANDA
Felodipine NDC 13668-134
Felodipine 10 mg/1 · Tablet, Extended release · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-134-01 | 1366801340113668013401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-01)Marketed from Nov 28, 2011 | |
| 13668-134-05 | 1366801340513668013405 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-05)Marketed from Nov 28, 2011 | |
| 13668-134-10 | 1366801341013668013410 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-10)Marketed from Nov 28, 2011 | |
| 13668-134-30 | 1366801343013668013430 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-30)Marketed from Nov 28, 2011 | |
| 13668-134-90 | 1366801349013668013490 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-90)Marketed from Nov 28, 2011 |
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, Extended release
- Route
- Oral
- Labeler
- Torrent Pharmaceuticals LimitedNDC labeler code 13668
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202170
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 13668-134_788121c3-8ac5-4592-b1c7-55466b849cceSPL ID 788121c3-8ac5-4592-b1c7-55466b849cceSPL set ID 60fb803e-ccf7-46f2-b506-e157ce440f87RxCUI 402695, 402696, 402698UNII OL961R6O2CUPC 0313668132304, 0313668134308
- 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
N413668013401followed by a unit qualifier and the quantityPackage 13668-0134-01. 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 are indicated for the treatment of hypertension. Felodipine extended-release tablets may be used alone or concomitantly with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
About NDC 13668-134
- What is NDC 13668-134?
- 13668-134 is the product NDC for Felodipine, Felodipine 10 mg/1 tablet, extended release, listed with the FDA by Torrent Pharmaceuticals Limited. It has 5 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?
- Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 202170
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 | Torrent Pharmaceuticals Limited | 13668-132 |
| Felodipine | Felodipine 5 mg/1 | Tablet, Extended releaseOral | Torrent Pharmaceuticals Limited | 13668-133 |
| Felodipine | Felodipine 2.5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2568 |
| Felodipine | Felodipine 10 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-1124 |