Felodipine
- Product NDC
- 13668-134
- 11-digit product format
- 136680134
- Labeler code
- 13668
- Product ID
- 13668-134_788121c3-8ac5-4592-b1c7-55466b849cce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felodipine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA202170
- Marketing category
- ANDA
- Marketing start
- 2011-11-28
- Substance
- FELODIPINE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Felodipine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FELODIPINE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OL961R6O2C |
| Rxcui | 402695, 402696, 402698 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-134-01 | Felodipine | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 8 |
| 13668-134-05 | Felodipine | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 8 |
| 13668-134-10 | Felodipine | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 8 |
| 13668-134-30 | Felodipine | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 8 |
| 13668-134-90 | Felodipine | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FELODIPINE | ACTIVE INGREDIENT | OL961R6O2C | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| FELODIPINE | ACTIVE MOIETY | OL961R6O2C | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| MAGNESIUM OXIDE | INACTIVE INGREDIENT | 3A3U0GI71G | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| POLYOXYL 40 HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | 7YC686GQ8F | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| PROPYL GALLATE | INACTIVE INGREDIENT | 8D4SNN7V92 | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-134 | FELODIPINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 7 | Current NDC, Legacy NDC, 5 package rows | 20241016_60fb803e-ccf7-46f2-b506-e157ce440f87.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13668-134-01 | 13668013401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-01) | 2011-11-28 | 0000-00-00 | No | No | Current |
| 13668-134-05 | 13668013405 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-05) | 2011-11-28 | 0000-00-00 | No | No | Current |
| 13668-134-10 | 13668013410 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-10) | 2011-11-28 | 0000-00-00 | No | No | Current |
| 13668-134-30 | 13668013430 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-30) | 2011-11-28 | 0000-00-00 | No | No | Current |
| 13668-134-74 | 13668013474 | 100 TABLET, EXTENDED RELEASE in 1 CARTON (13668-134-74) | 2011-11-28 | 0000-00-00 | No | No | Current |
| 13668-134-90 | 13668013490 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-90) | 2011-11-28 | 0000-00-00 | No | No | Current |