Felodipine

Product NDC: 71335-1318
11-digit product format: 713351318
Labeler code: 71335
Product ID: 71335-1318_308642fc-50f9-4828-9f7f-95375a26cf10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felodipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203417
Marketing category: ANDA
Marketing start: 2013-01-17
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 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
A203417-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17
A203417-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17
A203417-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203417-001	AB
A203417-002	AB
A203417-003	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	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`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	A203417-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203417-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203417-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203417-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203417-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203417-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203417-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203417-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203417-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203417-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203417-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203417-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203417-001	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	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
8eadbf3d-c93b-431c-aa86-559fc2a1d5a8	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
71335-1318-1	Felodipine	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1318	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	5	Current NDC, Legacy NDC, 1 package rows	20240407_8eadbf3d-c93b-431c-aa86-559fc2a1d5a8.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felodipine	FELODIPINE	Bryant Ranch Prepack	8eadbf3d-c93b-431c-aa86-559fc2a1d5a8	2024-04-03	Adverse reactions	Exact identifier application applno (ANDA): 203417 application number: ANDA203417 ndc (product): 71335-1318
Felodipine	FELODIPINE	Rising Pharma Holdings, Inc.	f5f56c59-04d5-4c5d-9441-5a93d3bdec82	2024-02-17	Adverse reactions	Exact identifier application applno (ANDA): 203417 application number: ANDA203417
Felodipine	FELODIPINE	Aurobindo Pharma Limited	dd39c559-5c5d-4d3b-9228-c44085e1699f	2024-02-17	Adverse reactions	Exact identifier application applno (ANDA): 203417 application number: ANDA203417
Felodipine	FELODIPINE	A-S Medication Solutions	be3bc927-1ba5-4cdd-9986-64ff29789d7e	2023-11-24	Adverse reactions	Exact identifier application applno (ANDA): 203417 application number: ANDA203417

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	8eadbf3d-c93b-431c-aa86-559fc2a1d5a8	5
402696	24 HR felodipine 5 MG Extended Release Oral Tablet	SCD	8eadbf3d-c93b-431c-aa86-559fc2a1d5a8	5
402696	felodipine 5 MG 24 HR Extended Release Oral Tablet	SY	8eadbf3d-c93b-431c-aa86-559fc2a1d5a8	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1318-1	71335131801	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1318-1)	2019-08-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Felodipine Extended-Release Tablets, USP Rx only	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	5