Felodipine

Product NDC
63629-5418
11-digit product format
636295418
Labeler code
63629
Product ID
63629-5418_f02fbc5c-1573-49f3-8cdf-53b61c42d0d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202170
Marketing category
ANDA
Marketing start
2011-11-28
Marketing end
0000-00-00
Substance
FELODIPINE
Active strength
3 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-5418DDiscontinued by firm2026-08-17
excluded packagepackage63629-541863629-5418-1DDiscontinued by firm2026-08-17

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 · 34 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-5418-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5418-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5418-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5418-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5418-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5418-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-5418-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-5418-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-5418-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-5418-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-5418-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-5418-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63629-5418-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63629-5418-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-5418-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-5418-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-5418-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A202170-001FELODIPINEFELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28
A202170-002FELODIPINEFELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28
A202170-003FELODIPINEFELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202170-001AB
A202170-002AB
A202170-003AB

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 06:07:402026-07A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202170-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202170-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALABRS2011-11-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202170-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2011-11-281e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202170-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202170-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202170-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202170-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202170-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202170-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202170-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202170-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202170-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202170-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202170-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202170-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202170-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202170-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202170-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202170-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202170-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202170-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202170-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202170-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202170-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202170-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202170-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202170-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202170-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202170-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202170-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202170-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202170-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202170-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202170-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202170-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202170-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202170-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202170-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202170-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202170-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202170-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202170-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202170-001AB11e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FELODIPINEACTIVE INGREDIENTOL961R6O2CFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
FELODIPINEACTIVE MOIETYOL961R6O2CFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92FELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FelodipineFELODIPINEA-S Medication Solutionse83f5688-55fd-492c-b0d6-e1028d12d6182026-06-10Adverse reactionsExact identifier
application applno (ANDA): 202170
application number: ANDA202170
FelodipineFELODIPINETorrent Pharmaceuticals Limited60fb803e-ccf7-46f2-b506-e157ce440f872026-02-09Adverse reactionsExact identifier
application applno (ANDA): 202170
application number: ANDA202170
FelodipineFELODIPINEBryant Ranch Prepack57fb4217-00f6-4112-bc63-81fcbe2ea9032025-11-17Adverse reactionsExact identifier
application applno (ANDA): 202170
application number: ANDA202170