Felodipine

Product NDC
50090-4808
11-digit product format
500904808
Labeler code
50090
Product ID
50090-4808_f0dadf86-3448-4318-93c0-676875379422
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine Extended-release Tablets
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210847
Marketing category
ANDA
Marketing start
2019-08-01
Marketing end
0000-00-00
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
2022-12-31
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 productproduct50090-4808IInactivated by FDA2026-08-03
excluded packagepackage50090-480850090-4808-0IInactivated by FDA2026-08-03

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 · 30 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 packagepackage50090-4808-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4808-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4808-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4808-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4808-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4808-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4808-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4808-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4808-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4808-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4808-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4808-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4808-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4808-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4808-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210847-001FELODIPINEFELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26
A210847-002FELODIPINEFELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26
A210847-003FELODIPINEFELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210847-001AB
A210847-002AB
A210847-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210847-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210847-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2018-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210847-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-10-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210847-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210847-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210847-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210847-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210847-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210847-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210847-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210847-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210847-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210847-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210847-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210847-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210847-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210847-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210847-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210847-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210847-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210847-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210847-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210847-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210847-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210847-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210847-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210847-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210847-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210847-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210847-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210847-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210847-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210847-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210847-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210847-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210847-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210847-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210847-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210847-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210847-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210847-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210847-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210847-001AB18072bd15b7f6…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4808-02023-01-30C16284748780-1f386c649-f811-0266-e053-dadaa90a7c1aFELODIPINE EXTENDED-RELEASE TABLETS, USP 2.5mg, 5mg and 10mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4808-0Felodipine30 in 1 BOTTLETABLET, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4808FELODIPINE (FELODIPINE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20210615_e7c2a381-3adf-455b-bbb7-8d557ed9349f.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FelodipineFELODIPINE EXTENDED-RELEASE TABLETSYiling Pharmaceutical Inc.7990a581-3e0f-5d8c-e053-2991aa0aa6a72025-12-29Adverse reactionsExact identifier
application applno (ANDA): 210847
application number: ANDA210847
FelodipineFELODIPINEChartwell RX, LLCfddebfce-70ed-4ee1-8598-bbb8f1ca92632025-12-10Adverse reactionsExact identifier
application applno (ANDA): 210847
application number: ANDA210847
FelopdipineFELODIPINEA-S Medication Solutions129c48eb-29f2-462b-ad8a-b3bf1b1931152024-08-07Adverse reactionsExact identifier
application applno (ANDA): 210847
application number: ANDA210847
FelodipineFELODIPINEWestminster Pharmaceuticals, LLCa6560584-e39f-47b3-84db-95da1f90fd402023-04-04Adverse reactionsExact identifier
application applno (ANDA): 210847
application number: ANDA210847

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSNe7c2a381-3adf-455b-bbb7-8d557ed9349f3
40269524 HR felodipine 10 MG Extended Release Oral TabletSCDe7c2a381-3adf-455b-bbb7-8d557ed9349f3
402695felodipine 10 MG 24 HR Extended Release Oral TabletSYe7c2a381-3adf-455b-bbb7-8d557ed9349f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4808-05009048080030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4808-0) 2019-12-240000-00-00NoNoCurrent