Felodipine
- Product NDC
- 68462-234
- 11-digit product format
- 684620234
- Labeler code
- 68462
- Product ID
- 68462-234_8663994d-841f-427a-93db-b4c9d10bad27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felodipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090365
- Marketing category
- ANDA
- Marketing start
- 2010-12-20
- Substance
- FELODIPINE
- Active strength
- 5 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 | 5 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 |
|---|
| 68462-234-01 | Felodipine | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 7 |
| 68462-234-10 | Felodipine | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 7 |
| 68462-234-11 | Felodipine | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | | 7 |
| 68462-234-11 | Felodipine | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 7 |
| 68462-234-90 | Felodipine | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FELODIPINE | ACTIVE INGREDIENT | OL961R6O2C | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| FELODIPINE | ACTIVE MOIETY | OL961R6O2C | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| KAOLIN | INACTIVE INGREDIENT | 24H4NWX5CO | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| POLYOXYL 40 HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | 7YC686GQ8F | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-234 | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | Current NDC, Legacy NDC, 5 package rows | 20181219_2e4298cf-02e9-49c7-9803-887161e1989a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68462-234-01 | 68462023401 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-234-01) | | 2010-12-20 | 0000-00-00 | No | No | Current |
| 68462-234-10 | 68462023410 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-234-10) | | 2010-12-20 | 0000-00-00 | No | No | Current |
| 68462-234-11 | 68462023411 | 10 BLISTER PACK in 1 CARTON (68462-234-11) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2010-12-20 | 0000-00-00 | No | No | Current |
| 68462-234-90 | 68462023490 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-234-90) | | 2010-12-20 | 0000-00-00 | No | No | Current |