Felodipine

Product NDC: 63629-2016
11-digit product format: 636292016
Labeler code: 63629
Product ID: 63629-2016_94eca4d7-4fe9-4729-b67b-b99d31b46917
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felodipine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA204800
Marketing category: ANDA
Marketing start: 2020-10-12
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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
2026-08-18 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204800-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204800-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204800-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204800-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204800-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204800-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204800-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204800-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204800-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204800-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204800-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204800-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204800-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Felodipine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FELODIPINE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OL961R6O2C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
402695	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
78341a0a-1274-417e-ae69-e133ee0480f9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6921cf71-4378-4166-972a-87039a02b9f2	Product name	5	20201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-2016-1	Felodipine	500 in 1 BOTTLE	TABLET, FILM COATED	500		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2016-1	EA - Each	63629-2016	2c31f41c-da07-4bc0-bf1c-180a673630d7	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2016	FELODIPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 1 package rows	20241122_78341a0a-1274-417e-ae69-e133ee0480f9.zip

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 ndc (product): 63629-2016
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
402695	felodipine 10 MG 24HR Extended Release Oral Tablet	PSN	78341a0a-1274-417e-ae69-e133ee0480f9	104
402695	24 HR felodipine 10 MG Extended Release Oral Tablet	SCD	78341a0a-1274-417e-ae69-e133ee0480f9	104
402695	felodipine 10 MG 24 HR Extended Release Oral Tablet	SY	78341a0a-1274-417e-ae69-e133ee0480f9	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2016-1	63629201601	500 TABLET, FILM COATED in 1 BOTTLE (63629-2016-1)	2020-10-12	0000-00-00	No	No	Current