Felodipine
- Product NDC
- 0603-3582
- 11-digit product format
- 006033582
- Labeler code
- 0603
- Product ID
- 0603-3582_ca215c73-f6f1-492c-810c-876e46001086
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felodipine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA200815
- Marketing category
- ANDA
- Marketing start
- 2011-12-15
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Felodipine
- Listing expiration
- 2026-12-31
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 |
|---|
| 0603-3582-21 | Felodipine | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 14 |
| 0603-3582-28 | Felodipine | 500 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 500 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FELODIPINE | ACTIVE INGREDIENT | OL961R6O2C | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| FELODIPINE | ACTIVE MOIETY | OL961R6O2C | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| CALCIUM SILICATE | INACTIVE INGREDIENT | S4255P4G5M | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| PEG-40 CASTOR OIL | INACTIVE INGREDIENT | 4ERD2076EF | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| PROPYL GALLATE | INACTIVE INGREDIENT | 8D4SNN7V92 | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [QUALITEST PHARMACEUTICALS] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0603-3582 | FELODIPINE TABLET, EXTENDED RELEASE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [ENDO USA, INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20241114_55637724-8757-11de-8a39-0800200c9a66.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 |
|---|
| 0603-3582-21 | 00603358221 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3582-21) | 2011-12-15 | 0000-00-00 | No | No | Current |
| 0603-3582-28 | 00603358228 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3582-28) | 2011-12-15 | 0000-00-00 | No | No | Current |