FELODIPINE

Product NDC
55648-412
11-digit product format
556480412
Labeler code
55648
Product ID
55648-412_a0bf854d-54eb-42f1-891b-3facd48042f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FELODIPINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA091484
Marketing category
ANDA
Marketing start
2010-12-05
Marketing end
0000-00-00
Substance
FELODIPINE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55648-412IInactivated by FDA2026-08-17
excluded packagepackage55648-41255648-412-01IInactivated by FDA2026-08-17
excluded packagepackage55648-41255648-412-02IInactivated by FDA2026-08-17
excluded packagepackage55648-41255648-412-03IInactivated by FDA2026-08-17
excluded packagepackage55648-41255648-412-04IInactivated by FDA2026-08-17

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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-412-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-412-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-412-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-412-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-412-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-412-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-412-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-412-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-412-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-412-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-412-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-412-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-412-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-412-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-412-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-412-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-412-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-412-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-412-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-412-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-412-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-412-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-412-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-412-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-412-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-412-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-412-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-412-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-412-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-412-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-412-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-412-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-412-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-412-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-412-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-412-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-412-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-412-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-412-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-412-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-412-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-412-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-412-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-412-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-412-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-412-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-412-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-412-02557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091484-001FELODIPINEFELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15
A091484-002FELODIPINEFELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15
A091484-003FELODIPINEFELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-15

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091484-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORAL2012-08-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091484-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORAL2012-08-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091484-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORAL2012-08-151e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6921cf71-4378-4166-972a-87039a02b9f2Product name520201015

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-412-01FELODIPINE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
55648-412-02FELODIPINE100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001
55648-412-03FELODIPINE10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE101
55648-412-03FELODIPINE10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE101
55648-412-04FELODIPINE500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FELODIPINEACTIVE INGREDIENTOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
FELODIPINEACTIVE MOIETYOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-412FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1Legacy NDC, 5 package rows20120816_b4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSNb4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c1
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSNb4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c1
402696felodipine 5 MG 24HR Extended Release Oral TabletPSNb4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c1
40269524 HR felodipine 10 MG Extended Release Oral TabletSCDb4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c1
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCDb4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c1
40269624 HR felodipine 5 MG Extended Release Oral TabletSCDb4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c1
402695felodipine 10 MG 24 HR Extended Release Oral TabletSYb4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c1
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSYb4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c1
402696felodipine 5 MG 24 HR Extended Release Oral TabletSYb4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-412-015564804120130 in 1 BOTTLEHistorical
55648-412-0255648041202100 in 1 BOTTLEHistorical
55648-412-035564804120310 in 1 CARTONHistorical
55648-412-0455648041204500 in 1 BOTTLEHistorical