Felodipine
- Product NDC
- 53489-370
- 11-digit product format
- 534890370
- Labeler code
- 53489
- Product ID
- 53489-370_6b871b9b-1cce-44db-a487-93cd6a6bb9cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felodipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA075896
- Marketing category
- ANDA
- Marketing start
- 2004-11-02
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FELODIPINE | ACTIVE INGREDIENT | OL961R6O2C | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FELODIPINE | ACTIVE MOIETY | OL961R6O2C | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
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 |
|---|
| 53489-370-01 | 53489037001 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-370-01) | 2004-11-02 | 0000-00-00 | No | No | Current |
| 53489-370-03 | 53489037003 | 250 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-370-03) | 2004-11-02 | 0000-00-00 | No | No | Current |
| 53489-370-05 | 53489037005 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-370-05) | 2004-11-02 | 0000-00-00 | No | No | Current |
| 53489-370-07 | 53489037007 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-370-07) | 2004-11-02 | 0000-00-00 | No | No | Current |
| 53489-370-10 | 53489037010 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-370-10) | 2004-11-02 | 0000-00-00 | No | No | Current |
| 53489-370-90 | 53489037090 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-370-90) | 2004-11-02 | 0000-00-00 | No | No | Current |