FELODIPINE

Product NDC: 63126-321
11-digit product format: 631260321
Labeler code: 63126
Product ID: 63126-321_ed33130e-be8c-4d3d-9c18-42f3f72fc716
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FELODIPINE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Yung Shin Pharmaceutical Ind. Co., Ltd.
Application: ANDA204800
Marketing category: ANDA
Marketing start: 2019-08-30
Marketing end: 0000-00-00
Substance: FELODIPINE
Active strength: 3 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204800-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29
A204800-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29
A204800-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204800-001	AB
A204800-002	AB
A204800-003	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.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A204800-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204800-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204800-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204800-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204800-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204800-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204800-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204800-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204800-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204800-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204800-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204800-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204800-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204800-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204800-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204800-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204800-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204800-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204800-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204800-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204800-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204800-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204800-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204800-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204800-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204800-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204800-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204800-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204800-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204800-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204800-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204800-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204800-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204800-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204800-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204800-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204800-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204800-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204800-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204800-003	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felodipine	FELODIPINE	Bryant Ranch Prepack	2daac7f7-66a8-4be7-b7de-4f1e60bb21f9	2025-04-01	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Bryant Ranch Prepack	b410a9aa-2014-4c25-8a54-2987477650e3	2025-04-01	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Bryant Ranch Prepack	063e633b-03ca-46e2-b6a0-8a300fccee93	2025-04-01	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Bryant Ranch Prepack	ca1c3b54-15a1-4252-938a-0d90f3bec4c5	2025-03-31	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Bryant Ranch Prepack	5c7b7f9a-4f4c-4259-8aae-fdb91ab09eec	2025-03-19	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Bryant Ranch Prepack	782c981d-419a-4fe4-ba44-087731642c78	2025-03-19	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Golden State Medical Supply, Inc.	bdd41c3a-c537-02f3-e053-2995a90a8929	2025-02-24	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Carlsbad Technology, Inc.	7bd4fa00-f0d8-4aea-9c24-a799b05e60e1	2025-02-18	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Bryant Ranch Prepack	78341a0a-1274-417e-ae69-e133ee0480f9	2024-11-20	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Proficient Rx LP	2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd	2022-04-01	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OL961R6O2C	FELODIPINE	72509-76-3	FELODIPINE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FELODIPINE EXTENDED-RELEASE TABLETS, USP	Yung Shin Pharmaceutical Ind. Co., Ltd.	2019-05-03	HUMAN PRESCRIPTION DRUG LABEL	2