Felodipine

Product NDC: 62135-647
11-digit product format: 621350647
Labeler code: 62135
Product ID: 62135-647_459bc915-c26d-844b-e063-6394a90a5c13
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felodipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA210847
Marketing category: ANDA
Marketing start: 2019-08-01
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
A210847-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26
A210847-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26
A210847-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210847-001	AB
A210847-002	AB
A210847-003	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	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`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	A210847-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210847-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210847-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210847-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210847-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210847-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210847-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210847-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210847-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210847-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210847-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210847-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210847-001	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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
402695	Internal RxNorm lookup
402696	Internal RxNorm lookup
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
fddebfce-70ed-4ee1-8598-bbb8f1ca9263	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
62135-647-90	Felodipine	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-647-90	EA - Each	62135-647	0101db3b-ff6a-430c-9558-abf5169baa9f	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-647	FELODIPINE TABLET, EXTENDED RELEASE [CHARTWELL RX, LLC]	2	Current NDC, 1 package rows	20241030_fddebfce-70ed-4ee1-8598-bbb8f1ca9263.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 EXTENDED-RELEASE TABLETS	Yiling Pharmaceutical Inc.	7990a581-3e0f-5d8c-e053-2991aa0aa6a7	2025-12-29	Adverse reactions	Exact identifier application applno (ANDA): 210847 application number: ANDA210847
Felodipine	FELODIPINE	Chartwell RX, LLC	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	2025-12-10	Adverse reactions	Exact identifier application applno (ANDA): 210847 application number: ANDA210847 ndc (product): 62135-647
Felopdipine	FELODIPINE	A-S Medication Solutions	129c48eb-29f2-462b-ad8a-b3bf1b193115	2024-08-07	Adverse reactions	Exact identifier application applno (ANDA): 210847 application number: ANDA210847
Felodipine	FELODIPINE	Westminster Pharmaceuticals, LLC	a6560584-e39f-47b3-84db-95da1f90fd40	2023-04-04	Adverse reactions	Exact identifier application applno (ANDA): 210847 application number: ANDA210847

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	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	3
402698	felodipine 2.5 MG 24HR Extended Release Oral Tablet	PSN	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	3
402696	felodipine 5 MG 24HR Extended Release Oral Tablet	PSN	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	3
402695	24 HR felodipine 10 MG Extended Release Oral Tablet	SCD	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	3
402698	24 HR felodipine 2.5 MG Extended Release Oral Tablet	SCD	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	3
402696	24 HR felodipine 5 MG Extended Release Oral Tablet	SCD	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	3
402695	felodipine 10 MG 24 HR Extended Release Oral Tablet	SY	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	3
402698	felodipine 2.5 MG 24 HR Extended Release Oral Tablet	SY	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	3
402696	felodipine 5 MG 24 HR Extended Release Oral Tablet	SY	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
62135-647-90	62135064790	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-647-90)	2023-06-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FELODIPINE EXTENDED-RELEASE TABLETS, USP 2.5mg, 5mg and 10mg	Chartwell RX, LLC	2025-12-10	HUMAN PRESCRIPTION DRUG LABEL	3