FELODIPINE
- Product NDC
- 64679-412
- 11-digit product format
- 646790412
- Labeler code
- 64679
- Product ID
- 64679-412_8e372057-db1b-4820-9721-8b7b9175dda3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- felodipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Wockhardt USA LLC.
- 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
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
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 USA LLC] | 1 | |
| FELODIPINE | ACTIVE MOIETY | OL961R6O2C | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
| POLYOXYL 40 HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | 7YC686GQ8F | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64679-412 | FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.] | 3 | Legacy NDC | 20191128_aac77fa1-04ad-497e-bbed-a21f538064c3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64679-412-01 | 64679041201 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-412-01) | | 2010-12-05 | 0000-00-00 | No | No | Current |
| 64679-412-02 | 64679041202 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-412-02) | | 2010-12-05 | 0000-00-00 | No | No | Current |
| 64679-412-03 | 64679041203 | 10 BLISTER PACK in 1 CARTON (64679-412-03) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2010-12-05 | 0000-00-00 | No | No | Current |
| 64679-412-04 | 64679041204 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-412-04) | | 2010-12-05 | 0000-00-00 | No | No | Current |