Felodipine

Product NDC: 65862-675
Requested package NDC: 65862-675-22
11-digit product format: 658620675
Labeler code: 65862
Product ID: 65862-675_a8579789-363a-44b3-be60-fe7bad9b16a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felodipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA203417
Marketing category: ANDA
Marketing start: 2013-01-17
Substance: FELODIPINE
Active strength: 10 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	65862-675	65862-675-22	UNFINISHED	Active or certified unfinished drug listing		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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	10 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
dd39c559-5c5d-4d3b-9228-c44085e1699f	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	SPL version
65862-675-01	Felodipine	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	4
65862-675-10	Felodipine	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10	4
65862-675-78	Felodipine	10 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	10	4
65862-675-90	Felodipine	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	4
65862-675-99	Felodipine	1000 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	1000	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-675-01	EA - Each	65862-675	2ba46188-24e0-4777-a164-aa03cf5c556b	1	2014-01-04
65862-675-99	EA - Each	65862-675	74fae1a3-6370-4a99-8398-bbf510c6f668	1	2014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FELODIPINE	ACTIVE INGREDIENT	OL961R6O2C	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
FELODIPINE	ACTIVE MOIETY	OL961R6O2C	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
ALUMINUM SILICATE	INACTIVE INGREDIENT	T1FAD4SS2M	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-675	FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	4	Current NDC, Legacy NDC, 5 package rows	20240218_dd39c559-5c5d-4d3b-9228-c44085e1699f.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
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 ndc (product): 65862-675
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
402695	felodipine 10 MG 24HR Extended Release Oral Tablet	PSN	dd39c559-5c5d-4d3b-9228-c44085e1699f	4
402698	felodipine 2.5 MG 24HR Extended Release Oral Tablet	PSN	dd39c559-5c5d-4d3b-9228-c44085e1699f	4
402696	felodipine 5 MG 24HR Extended Release Oral Tablet	PSN	dd39c559-5c5d-4d3b-9228-c44085e1699f	4
402695	24 HR felodipine 10 MG Extended Release Oral Tablet	SCD	dd39c559-5c5d-4d3b-9228-c44085e1699f	4
402698	24 HR felodipine 2.5 MG Extended Release Oral Tablet	SCD	dd39c559-5c5d-4d3b-9228-c44085e1699f	4
402696	24 HR felodipine 5 MG Extended Release Oral Tablet	SCD	dd39c559-5c5d-4d3b-9228-c44085e1699f	4
402695	felodipine 10 MG 24 HR Extended Release Oral Tablet	SY	dd39c559-5c5d-4d3b-9228-c44085e1699f	4
402698	felodipine 2.5 MG 24 HR Extended Release Oral Tablet	SY	dd39c559-5c5d-4d3b-9228-c44085e1699f	4
402696	felodipine 5 MG 24 HR Extended Release Oral Tablet	SY	dd39c559-5c5d-4d3b-9228-c44085e1699f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-675-22	65862067522	2000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (65862-675-22)	17-JAN-13	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Felodipine - Aurobindo Pharma Limited	Aurobindo Pharma Limited	2024-02-17	Human Prescription Drug Label	4