Felodipine

Product NDC
57237-108
11-digit product format
572370108
Labeler code
57237
Product ID
57237-108_9ea82ae9-2d77-4da4-8213-dda2434df9d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA203417
Marketing category
ANDA
Marketing start
2013-01-17
Substance
FELODIPINE
Active strength
2.5 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

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
A203417-001FELODIPINEFELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17
A203417-002FELODIPINEFELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17
A203417-003FELODIPINEFELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203417-001AB
A203417-002AB
A203417-003AB

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 06:07:402026-07A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203417-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203417-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2013-01-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203417-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2013-01-171e350fbaab3a…

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 06:07:402026-07A203417-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203417-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203417-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203417-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203417-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203417-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203417-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203417-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203417-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203417-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203417-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203417-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203417-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203417-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203417-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203417-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203417-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203417-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203417-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203417-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203417-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203417-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203417-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203417-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203417-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203417-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203417-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203417-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203417-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203417-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203417-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203417-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203417-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203417-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203417-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203417-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203417-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203417-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203417-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203417-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Felodipine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FELODIPINE2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OL961R6O2CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402695Internal RxNorm lookup
402696Internal RxNorm lookup
402698Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5f56c59-04d5-4c5d-9441-5a93d3bdec82Available on FDA.report

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
57237-108-01Felodipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-108-01EA - Each57237-1080b49264d-c97d-4184-a7f4-2efea898872e12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FELODIPINEACTIVE INGREDIENTOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
FELODIPINEACTIVE MOIETYOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
ALUMINUM SILICATEINACTIVE INGREDIENTT1FAD4SS2MFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-108FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]6Current NDC, Legacy NDC, 1 package rows20240222_f5f56c59-04d5-4c5d-9441-5a93d3bdec82.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
FelodipineFELODIPINEBryant Ranch Prepack8eadbf3d-c93b-431c-aa86-559fc2a1d5a82024-04-03Adverse reactionsExact identifier
application applno (ANDA): 203417
application number: ANDA203417
FelodipineFELODIPINERising Pharma Holdings, Inc.f5f56c59-04d5-4c5d-9441-5a93d3bdec822024-02-17Adverse reactionsExact identifier
application applno (ANDA): 203417
application number: ANDA203417
ndc (product): 57237-108
FelodipineFELODIPINEAurobindo Pharma Limiteddd39c559-5c5d-4d3b-9228-c44085e1699f2024-02-17Adverse reactionsExact identifier
application applno (ANDA): 203417
application number: ANDA203417
FelodipineFELODIPINEA-S Medication Solutionsbe3bc927-1ba5-4cdd-9986-64ff29789d7e2023-11-24Adverse reactionsExact identifier
application applno (ANDA): 203417
application number: ANDA203417

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSNf5f56c59-04d5-4c5d-9441-5a93d3bdec826
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSNf5f56c59-04d5-4c5d-9441-5a93d3bdec826
402696felodipine 5 MG 24HR Extended Release Oral TabletPSNf5f56c59-04d5-4c5d-9441-5a93d3bdec826
40269524 HR felodipine 10 MG Extended Release Oral TabletSCDf5f56c59-04d5-4c5d-9441-5a93d3bdec826
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCDf5f56c59-04d5-4c5d-9441-5a93d3bdec826
40269624 HR felodipine 5 MG Extended Release Oral TabletSCDf5f56c59-04d5-4c5d-9441-5a93d3bdec826
402695felodipine 10 MG 24 HR Extended Release Oral TabletSYf5f56c59-04d5-4c5d-9441-5a93d3bdec826
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSYf5f56c59-04d5-4c5d-9441-5a93d3bdec826
402696felodipine 5 MG 24 HR Extended Release Oral TabletSYf5f56c59-04d5-4c5d-9441-5a93d3bdec826

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-108-0157237010801100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-108-01) 2013-01-170000-00-00NoNoCurrent