FELODIPINE

Product NDC: 23155-049
11-digit product format: 231550049
Labeler code: 23155
Product ID: 23155-049_c39f92ed-6e77-4742-b4e4-deec031f1e31
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FELODIPINE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA201964
Marketing category: ANDA
Marketing start: 2013-11-08
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
A201964-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08
A201964-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08
A201964-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201964-001	AB
A201964-002	AB
A201964-003	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	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201964-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201964-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201964-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-08	`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	A201964-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201964-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201964-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201964-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201964-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201964-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201964-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201964-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201964-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201964-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201964-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201964-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201964-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201964-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201964-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201964-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201964-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201964-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201964-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201964-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201964-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201964-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201964-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201964-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201964-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201964-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201964-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201964-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201964-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201964-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201964-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201964-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201964-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201964-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201964-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201964-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201964-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201964-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201964-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201964-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: FELODIPINE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FELODIPINE	5 mg/1

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
23155-049-01	FELODIPINE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		7
23155-049-05	FELODIPINE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23155-049-01	EA - Each	23155-049	3ada6e9d-cc0f-4cd8-bf29-79dbb3cfc0b7	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FELODIPINE	ACTIVE INGREDIENT	OL961R6O2C	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
FELODIPINE	ACTIVE MOIETY	OL961R6O2C	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23155-049	FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 2 package rows	20230721_0bef7cf2-012b-4804-ac93-0a8b333035db.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FELODIPINE	FELODIPINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	0bef7cf2-012b-4804-ac93-0a8b333035db	2026-08-11	Adverse reactions	Exact identifier application applno (ANDA): 201964 application number: ANDA201964 ndc (product): 23155-049

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	0bef7cf2-012b-4804-ac93-0a8b333035db	7
402698	felodipine 2.5 MG 24HR Extended Release Oral Tablet	PSN	0bef7cf2-012b-4804-ac93-0a8b333035db	7
402696	felodipine 5 MG 24HR Extended Release Oral Tablet	PSN	0bef7cf2-012b-4804-ac93-0a8b333035db	7
402695	24 HR felodipine 10 MG Extended Release Oral Tablet	SCD	0bef7cf2-012b-4804-ac93-0a8b333035db	7
402698	24 HR felodipine 2.5 MG Extended Release Oral Tablet	SCD	0bef7cf2-012b-4804-ac93-0a8b333035db	7
402696	24 HR felodipine 5 MG Extended Release Oral Tablet	SCD	0bef7cf2-012b-4804-ac93-0a8b333035db	7
402695	felodipine 10 MG 24 HR Extended Release Oral Tablet	SY	0bef7cf2-012b-4804-ac93-0a8b333035db	7
402698	felodipine 2.5 MG 24 HR Extended Release Oral Tablet	SY	0bef7cf2-012b-4804-ac93-0a8b333035db	7
402696	felodipine 5 MG 24 HR Extended Release Oral Tablet	SY	0bef7cf2-012b-4804-ac93-0a8b333035db	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
23155-049-01	23155004901	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-049-01)	2013-11-08	0000-00-00	No	No	Current
23155-049-05	23155004905	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-049-05)	2013-11-08	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 Rx only	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| USV Private Limited	2026-08-11	HUMAN PRESCRIPTION DRUG LABEL	8