Felodipine

Product NDC: 72162-2568
11-digit product format: 721622568
Labeler code: 72162
Product ID: 72162-2568_7068c99c-1af6-49b7-8157-82786539576f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felodipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202170
Marketing category: ANDA
Marketing start: 2011-11-28
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

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	RLD / RS	Approval date
A202170-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28
A202170-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28
A202170-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202170-001	AB
A202170-002	AB
A202170-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202170-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202170-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202170-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-11-28	`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	A202170-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202170-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202170-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202170-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202170-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202170-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202170-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202170-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202170-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202170-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202170-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202170-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202170-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202170-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202170-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202170-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202170-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202170-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202170-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202170-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202170-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202170-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202170-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202170-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202170-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202170-001	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	2.5 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
402698	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
57fb4217-00f6-4112-bc63-81fcbe2ea903	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6921cf71-4378-4166-972a-87039a02b9f2	Product name	5	20201015
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-2568-1	Felodipine	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2568-1	EA - Each	72162-2568	737a7bb0-2b7a-4442-94a0-9f068ceaf360	1	2026-01-08

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felodipine	FELODIPINE	A-S Medication Solutions	e83f5688-55fd-492c-b0d6-e1028d12d618	2026-06-10	Adverse reactions	Exact identifier application applno (ANDA): 202170 application number: ANDA202170
Felodipine	FELODIPINE	Torrent Pharmaceuticals Limited	60fb803e-ccf7-46f2-b506-e157ce440f87	2026-02-09	Adverse reactions	Exact identifier application applno (ANDA): 202170 application number: ANDA202170
Felodipine	FELODIPINE	Bryant Ranch Prepack	57fb4217-00f6-4112-bc63-81fcbe2ea903	2025-11-17	Adverse reactions	Exact identifier application applno (ANDA): 202170 application number: ANDA202170 ndc (product): 72162-2568

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
402698	felodipine 2.5 MG 24HR Extended Release Oral Tablet	PSN	57fb4217-00f6-4112-bc63-81fcbe2ea903	100
402698	24 HR felodipine 2.5 MG Extended Release Oral Tablet	SCD	57fb4217-00f6-4112-bc63-81fcbe2ea903	100
402698	felodipine 2.5 MG 24 HR Extended Release Oral Tablet	SY	57fb4217-00f6-4112-bc63-81fcbe2ea903	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72162-2568-1	72162256801	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2568-1)	2025-11-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Felodipine Extended-Release Tablets, USP Rx only	Bryant Ranch Prepack	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	100