Felodipine
- Product NDC
- 57237-108
- 11-digit product format
- 572370108
- Labeler code
- 57237
- Product ID
- 57237-108_9ea82ae9-2d77-4da4-8213-dda2434df9d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felodipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA203417
- Marketing category
- ANDA
- Marketing start
- 2013-01-17
- Substance
- FELODIPINE
- Active strength
- 2.5 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203417-001 | FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | |
| A203417-002 | FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | |
| A203417-003 | FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203417-001 | AB |
| A203417-002 | AB |
| A203417-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203417-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203417-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203417-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-01-17 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A203417-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203417-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203417-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203417-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203417-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203417-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203417-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203417-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203417-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203417-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203417-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203417-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203417-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203417-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203417-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203417-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203417-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203417-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203417-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203417-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203417-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203417-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203417-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203417-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203417-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203417-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203417-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203417-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203417-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203417-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203417-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203417-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203417-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203417-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203417-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203417-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203417-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203417-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203417-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203417-001 | AB | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Felodipine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FELODIPINE | 2.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| OL961R6O2C | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f5f56c59-04d5-4c5d-9441-5a93d3bdec82 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6921cf71-4378-4166-972a-87039a02b9f2 | Product name | 5 | 20201015 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-108-01 | Felodipine | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-108-01 | EA - Each | 57237-108 | 0b49264d-c97d-4184-a7f4-2efea898872e | 1 | 2015-02-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Felodipine | FELODIPINE | Bryant Ranch Prepack | 8eadbf3d-c93b-431c-aa86-559fc2a1d5a8 | 2024-04-03 | Adverse reactions | 203417 ANDA203417 |
| Felodipine | FELODIPINE | Rising Pharma Holdings, Inc. | f5f56c59-04d5-4c5d-9441-5a93d3bdec82 | 2024-02-17 | Adverse reactions | 203417 ANDA203417 57237-108 |
| Felodipine | FELODIPINE | Aurobindo Pharma Limited | dd39c559-5c5d-4d3b-9228-c44085e1699f | 2024-02-17 | Adverse reactions | 203417 ANDA203417 |
| Felodipine | FELODIPINE | A-S Medication Solutions | be3bc927-1ba5-4cdd-9986-64ff29789d7e | 2023-11-24 | Adverse reactions | 203417 ANDA203417 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 402695 | felodipine 10 MG 24HR Extended Release Oral Tablet | PSN | f5f56c59-04d5-4c5d-9441-5a93d3bdec82 | 6 |
| 402698 | felodipine 2.5 MG 24HR Extended Release Oral Tablet | PSN | f5f56c59-04d5-4c5d-9441-5a93d3bdec82 | 6 |
| 402696 | felodipine 5 MG 24HR Extended Release Oral Tablet | PSN | f5f56c59-04d5-4c5d-9441-5a93d3bdec82 | 6 |
| 402695 | 24 HR felodipine 10 MG Extended Release Oral Tablet | SCD | f5f56c59-04d5-4c5d-9441-5a93d3bdec82 | 6 |
| 402698 | 24 HR felodipine 2.5 MG Extended Release Oral Tablet | SCD | f5f56c59-04d5-4c5d-9441-5a93d3bdec82 | 6 |
| 402696 | 24 HR felodipine 5 MG Extended Release Oral Tablet | SCD | f5f56c59-04d5-4c5d-9441-5a93d3bdec82 | 6 |
| 402695 | felodipine 10 MG 24 HR Extended Release Oral Tablet | SY | f5f56c59-04d5-4c5d-9441-5a93d3bdec82 | 6 |
| 402698 | felodipine 2.5 MG 24 HR Extended Release Oral Tablet | SY | f5f56c59-04d5-4c5d-9441-5a93d3bdec82 | 6 |
| 402696 | felodipine 5 MG 24 HR Extended Release Oral Tablet | SY | f5f56c59-04d5-4c5d-9441-5a93d3bdec82 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 57237-108-01 | 57237010801 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-108-01) | 2013-01-17 | 0000-00-00 | No | No | Current |