Felodipine

Product NDC: 63629-2196
11-digit product format: 636292196
Labeler code: 63629
Product ID: 63629-2196_478abcc5-1f40-455b-a479-c277d6e1de53
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felodipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A200815-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28
A200815-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28
A200815-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200815-001	AB
A200815-002	AB
A200815-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200815-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200815-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200815-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200815-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200815-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200815-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200815-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200815-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200815-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200815-001	AB	1	`8072bd15b7f6…`

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 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
402696	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
b27a13d4-c068-43c8-b654-b8b3276e468a	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
63629-2196-1	Felodipine	500 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	500		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2196-1	EA - Each	63629-2196	435acaf9-e605-4dff-9203-9b7a3d0de174	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2196	FELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 1 package rows	20241219_b27a13d4-c068-43c8-b654-b8b3276e468a.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felodipine	FELODIPINE	Bryant Ranch Prepack	b27a13d4-c068-43c8-b654-b8b3276e468a	2024-12-06	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815 ndc (product): 63629-2196
Felodipine	FELODIPINE	Bryant Ranch Prepack	db3fb41e-ed00-4fa9-b725-b8d9ba731de1	2024-12-06	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815
Felodipine	FELODIPINE	Bryant Ranch Prepack	3dbc3f1b-37a6-41af-9d4b-a61a12f6260b	2024-12-05	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815
Felodipine	FELODIPINE	Bryant Ranch Prepack	9b6deb61-f94e-4b21-adc9-37a1d188c9bd	2024-12-05	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815
Felodipine	FELODIPINE	Bryant Ranch Prepack	45e3094c-7755-48c2-be65-c0377f18a400	2024-12-05	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815
Felodipine	FELODIPINE	Endo USA, Inc.	55637724-8757-11de-8a39-0800200c9a66	2024-09-30	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815
Felodipine	FELODIPINE	Bryant Ranch Prepack	05feb0a1-8a0c-4d8a-9b86-5e700ea6fd64	2023-12-04	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815
Felodipine	FELODIPINE	Bryant Ranch Prepack	30d15f4b-a0ee-4841-ace3-dcaf52016953	2023-03-30	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815
Felodipine	FELODIPINE	Bryant Ranch Prepack	196ef773-8a2a-4ef7-a403-2341f94f4d98	2023-03-30	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815

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
402696	felodipine 5 MG 24HR Extended Release Oral Tablet	PSN	b27a13d4-c068-43c8-b654-b8b3276e468a	104
402696	24 HR felodipine 5 MG Extended Release Oral Tablet	SCD	b27a13d4-c068-43c8-b654-b8b3276e468a	104
402696	felodipine 5 MG 24 HR Extended Release Oral Tablet	SY	b27a13d4-c068-43c8-b654-b8b3276e468a	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2196-1	63629219601	500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-2196-1)	2011-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Felodipine Extended-Release Tablets, USP 2.5 mg, 5 mg and 10 mg R x only	Bryant Ranch Prepack	2024-12-06	HUMAN PRESCRIPTION DRUG LABEL	104