Felodipine
- Product NDC
- 68462-235
- 11-digit product format
- 684620235
- Labeler code
- 68462
- Product ID
- 68462-235_8663994d-841f-427a-93db-b4c9d10bad27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felodipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090365
- Marketing category
- ANDA
- Marketing start
- 2010-12-20
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090365-001 | FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | |
| A090365-002 | FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | |
| A090365-003 | FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090365-001 | AB |
| A090365-002 | AB |
| A090365-003 | 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 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090365-002 | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090365-003 | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090365-001 | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-17 | 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 | A090365-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090365-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090365-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090365-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090365-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090365-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090365-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090365-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090365-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090365-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090365-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090365-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090365-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090365-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090365-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090365-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090365-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090365-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090365-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090365-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090365-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090365-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090365-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090365-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090365-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090365-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090365-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090365-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090365-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090365-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090365-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090365-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090365-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090365-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090365-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090365-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090365-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090365-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090365-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090365-001 | AB | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Felodipine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FELODIPINE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| OL961R6O2C | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2e4298cf-02e9-49c7-9803-887161e1989a | 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 |
|---|---|---|---|---|---|---|
| 68462-235-01 | Felodipine | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | 7 | |
| 68462-235-10 | Felodipine | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | 7 | |
| 68462-235-11 | Felodipine | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | 7 | |
| 68462-235-11 | Felodipine | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | 7 | |
| 68462-235-90 | Felodipine | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-235-01 | EA - Each | 68462-235 | cfb0c3e4-2742-4e59-80de-4f98c28d1ec0 | 1 | 2012-07-24 |
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 | 924b2633-74bd-469f-b831-77f09dfebbf7 | 2026-06-23 | Adverse reactions | 090365 ANDA090365 |
| Felodipine | FELODIPINE | Glenmark Pharmaceuticals Inc., USA | 2e4298cf-02e9-49c7-9803-887161e1989a | 2026-01-23 | Adverse reactions | 090365 ANDA090365 68462-235 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 402695 | felodipine 10 MG 24HR Extended Release Oral Tablet | PSN | e0672664-c12a-429a-a04f-62b75fcfb0ae | 9 |
| 402695 | 24 HR felodipine 10 MG Extended Release Oral Tablet | SCD | e0672664-c12a-429a-a04f-62b75fcfb0ae | 9 |
| 402695 | felodipine 10 MG 24 HR Extended Release Oral Tablet | SY | e0672664-c12a-429a-a04f-62b75fcfb0ae | 9 |
| 402695 | felodipine 10 MG 24HR Extended Release Oral Tablet | PSN | 2e4298cf-02e9-49c7-9803-887161e1989a | 7 |
| 402698 | felodipine 2.5 MG 24HR Extended Release Oral Tablet | PSN | 2e4298cf-02e9-49c7-9803-887161e1989a | 7 |
| 402696 | felodipine 5 MG 24HR Extended Release Oral Tablet | PSN | 2e4298cf-02e9-49c7-9803-887161e1989a | 7 |
| 402695 | 24 HR felodipine 10 MG Extended Release Oral Tablet | SCD | 2e4298cf-02e9-49c7-9803-887161e1989a | 7 |
| 402698 | 24 HR felodipine 2.5 MG Extended Release Oral Tablet | SCD | 2e4298cf-02e9-49c7-9803-887161e1989a | 7 |
| 402696 | 24 HR felodipine 5 MG Extended Release Oral Tablet | SCD | 2e4298cf-02e9-49c7-9803-887161e1989a | 7 |
| 402695 | felodipine 10 MG 24 HR Extended Release Oral Tablet | SY | 2e4298cf-02e9-49c7-9803-887161e1989a | 7 |
| 402698 | felodipine 2.5 MG 24 HR Extended Release Oral Tablet | SY | 2e4298cf-02e9-49c7-9803-887161e1989a | 7 |
| 402696 | felodipine 5 MG 24 HR Extended Release Oral Tablet | SY | 2e4298cf-02e9-49c7-9803-887161e1989a | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68462-235-01 | 68462023501 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-235-01) | 2010-12-20 | 0000-00-00 | No | No | Current | |
| 68462-235-10 | 68462023510 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-235-10) | 2010-12-20 | 0000-00-00 | No | No | Current | |
| 68462-235-11 | 68462023511 | 10 BLISTER PACK in 1 CARTON (68462-235-11) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2010-12-20 | 0000-00-00 | No | No | Current |
| 68462-235-90 | 68462023590 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-235-90) | 2010-12-20 | 0000-00-00 | No | No | Current |