Felodipine

Product NDC
51407-087
11-digit product format
514070087
Labeler code
51407
Product ID
51407-087_c6143223-8632-96f0-e053-2a95a90ae5ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA204800
Marketing category
ANDA
Marketing start
2019-04-29
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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51407-087DDiscontinued by firm2026-08-17
excluded packagepackage51407-08751407-087-01DDiscontinued by firm2026-08-17
excluded packagepackage51407-08751407-087-05DDiscontinued 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 · 27 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 packagepackage51407-087-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51407-087-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51407-087-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51407-087-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51407-087-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51407-087-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51407-087-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51407-087-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51407-087-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51407-087-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51407-087-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51407-087-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51407-087-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51407-087-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51407-087-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51407-087-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51407-087-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51407-087-050efc9e666f02…f202fb6c5f17…

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
A204800-001FELODIPINEFELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29
A204800-002FELODIPINEFELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29
A204800-003FELODIPINEFELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204800-001AB
A204800-002AB
A204800-003AB

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 06:07:402026-07A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204800-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204800-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2019-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204800-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2019-04-291e350fbaab3a…

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 06:07:402026-07A204800-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204800-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204800-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204800-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204800-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204800-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204800-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204800-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204800-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204800-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204800-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204800-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204800-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204800-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204800-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204800-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204800-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204800-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204800-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204800-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204800-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204800-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204800-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204800-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204800-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204800-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204800-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204800-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204800-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204800-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204800-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204800-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204800-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204800-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204800-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204800-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204800-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204800-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204800-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204800-001AB11e350fbaab3a…

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-087-01Felodipine100 in 1 BOTTLETABLET, FILM COATED1007
51407-087-05Felodipine500 in 1 BOTTLETABLET, FILM COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-087-01EA - Each51407-087d9a84a11-77ae-4ebb-a453-825a12a6eb5d12021-04-08
51407-087-05EA - Each51407-0879986533c-7b70-4fb8-99f8-6d297598f8fc12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-087FELODIPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]7Legacy NDC, 2 package rows20250411_bdd41c3a-c537-02f3-e053-2995a90a8929.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FelodipineFELODIPINEBryant Ranch Prepack2daac7f7-66a8-4be7-b7de-4f1e60bb21f92025-04-01Adverse reactionsExact identifier
application applno (ANDA): 204800
application number: ANDA204800
FelodipineFELODIPINEBryant Ranch Prepackb410a9aa-2014-4c25-8a54-2987477650e32025-04-01Adverse reactionsExact identifier
application applno (ANDA): 204800
application number: ANDA204800
FelodipineFELODIPINEBryant Ranch Prepack063e633b-03ca-46e2-b6a0-8a300fccee932025-04-01Adverse reactionsExact identifier
application applno (ANDA): 204800
application number: ANDA204800
FelodipineFELODIPINEBryant Ranch Prepackca1c3b54-15a1-4252-938a-0d90f3bec4c52025-03-31Adverse reactionsExact identifier
application applno (ANDA): 204800
application number: ANDA204800
FelodipineFELODIPINEBryant Ranch Prepack5c7b7f9a-4f4c-4259-8aae-fdb91ab09eec2025-03-19Adverse reactionsExact identifier
application applno (ANDA): 204800
application number: ANDA204800
FelodipineFELODIPINEBryant Ranch Prepack782c981d-419a-4fe4-ba44-087731642c782025-03-19Adverse reactionsExact identifier
application applno (ANDA): 204800
application number: ANDA204800
FelodipineFELODIPINEGolden State Medical Supply, Inc.bdd41c3a-c537-02f3-e053-2995a90a89292025-02-24Adverse reactionsExact identifier
application applno (ANDA): 204800
application number: ANDA204800
ndc (product): 51407-087
FelodipineFELODIPINECarlsbad Technology, Inc.7bd4fa00-f0d8-4aea-9c24-a799b05e60e12025-02-18Adverse reactionsExact identifier
application applno (ANDA): 204800
application number: ANDA204800
FelodipineFELODIPINEBryant Ranch Prepack78341a0a-1274-417e-ae69-e133ee0480f92024-11-20Adverse reactionsExact identifier
application applno (ANDA): 204800
application number: ANDA204800
FelodipineFELODIPINEProficient Rx LP2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd2022-04-01Adverse reactionsExact identifier
application applno (ANDA): 204800
application number: ANDA204800

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSNbdd41c3a-c537-02f3-e053-2995a90a89297
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSNbdd41c3a-c537-02f3-e053-2995a90a89297
402696felodipine 5 MG 24HR Extended Release Oral TabletPSNbdd41c3a-c537-02f3-e053-2995a90a89297
40269524 HR felodipine 10 MG Extended Release Oral TabletSCDbdd41c3a-c537-02f3-e053-2995a90a89297
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCDbdd41c3a-c537-02f3-e053-2995a90a89297
40269624 HR felodipine 5 MG Extended Release Oral TabletSCDbdd41c3a-c537-02f3-e053-2995a90a89297
402695felodipine 10 MG 24 HR Extended Release Oral TabletSYbdd41c3a-c537-02f3-e053-2995a90a89297
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSYbdd41c3a-c537-02f3-e053-2995a90a89297
402696felodipine 5 MG 24 HR Extended Release Oral TabletSYbdd41c3a-c537-02f3-e053-2995a90a89297

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-087-0151407008701100 TABLET, FILM COATED in 1 BOTTLE (51407-087-01) 2020-03-130000-00-00NoNoCurrent
51407-087-0551407008705500 TABLET, FILM COATED in 1 BOTTLE (51407-087-05) 2020-03-130000-00-00NoNoCurrent