FELODIPINE
- Product NDC
- 55648-412
- 11-digit product format
- 556480412
- Labeler code
- 55648
- Product ID
- 55648-412_a0bf854d-54eb-42f1-891b-3facd48042f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FELODIPINE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- WOCKHARDT LIMITED
- Application
- ANDA091484
- Marketing category
- ANDA
- Marketing start
- 2010-12-05
- Marketing end
- 0000-00-00
- Substance
- FELODIPINE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55648-412-01 | FELODIPINE | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
| 55648-412-02 | FELODIPINE | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 1 |
| 55648-412-03 | FELODIPINE | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | | 1 |
| 55648-412-03 | FELODIPINE | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 1 |
| 55648-412-04 | FELODIPINE | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 1 |
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 [WOCKHARDT LIMITED] | 1 | |
| FELODIPINE | ACTIVE MOIETY | OL961R6O2C | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
| POLYOXYL 40 HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | 7YC686GQ8F | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55648-412 | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | Legacy NDC, 5 package rows | 20120816_b4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 55648-412-01 | 55648041201 | 30 in 1 BOTTLE | Historical |
| 55648-412-02 | 55648041202 | 100 in 1 BOTTLE | Historical |
| 55648-412-03 | 55648041203 | 10 in 1 CARTON | Historical |
| 55648-412-04 | 55648041204 | 500 in 1 BOTTLE | Historical |