Felodipine

Product NDC
68462-235
11-digit product format
684620235
Labeler code
68462
Product ID
68462-235_8663994d-841f-427a-93db-b4c9d10bad27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090365
Marketing category
ANDA
Marketing start
2010-12-20
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
2027-12-31
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
A090365-001FELODIPINEFELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17
A090365-002FELODIPINEFELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17
A090365-003FELODIPINEFELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090365-001AB
A090365-002AB
A090365-003AB

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 06:07:402026-07A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090365-002FELODIPINE5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090365-003FELODIPINE10MGTABLET, EXTENDED RELEASE / ORALAB2010-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090365-001FELODIPINE2.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-171e350fbaab3a…

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 06:07:402026-07A090365-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090365-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090365-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090365-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090365-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090365-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090365-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090365-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090365-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090365-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090365-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090365-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090365-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090365-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090365-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090365-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090365-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090365-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090365-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090365-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090365-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090365-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090365-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090365-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090365-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090365-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090365-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090365-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090365-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090365-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090365-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090365-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090365-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090365-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090365-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090365-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090365-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090365-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090365-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090365-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Felodipine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FELODIPINE10 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
2e4298cf-02e9-49c7-9803-887161e1989aAvailable 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
68462-235-01Felodipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1007
68462-235-10Felodipine1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10007
68462-235-11Felodipine10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE107
68462-235-11Felodipine10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE107
68462-235-90Felodipine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-235-01EA - Each68462-235cfb0c3e4-2742-4e59-80de-4f98c28d1ec012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FELODIPINEACTIVE INGREDIENTOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FELODIPINEACTIVE MOIETYOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
KAOLININACTIVE INGREDIENT24H4NWX5COFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-235FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]6Current NDC, Legacy NDC, 5 package rows20181219_2e4298cf-02e9-49c7-9803-887161e1989a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FelodipineFELODIPINEBryant Ranch Prepack924b2633-74bd-469f-b831-77f09dfebbf72026-06-23Adverse reactionsExact identifier
application applno (ANDA): 090365
application number: ANDA090365
FelodipineFELODIPINEGlenmark Pharmaceuticals Inc., USA2e4298cf-02e9-49c7-9803-887161e1989a2026-01-23Adverse reactionsExact identifier
application applno (ANDA): 090365
application number: ANDA090365
ndc (product): 68462-235

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSNe0672664-c12a-429a-a04f-62b75fcfb0ae9
40269524 HR felodipine 10 MG Extended Release Oral TabletSCDe0672664-c12a-429a-a04f-62b75fcfb0ae9
402695felodipine 10 MG 24 HR Extended Release Oral TabletSYe0672664-c12a-429a-a04f-62b75fcfb0ae9
402695felodipine 10 MG 24HR Extended Release Oral TabletPSN2e4298cf-02e9-49c7-9803-887161e1989a7
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSN2e4298cf-02e9-49c7-9803-887161e1989a7
402696felodipine 5 MG 24HR Extended Release Oral TabletPSN2e4298cf-02e9-49c7-9803-887161e1989a7
40269524 HR felodipine 10 MG Extended Release Oral TabletSCD2e4298cf-02e9-49c7-9803-887161e1989a7
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCD2e4298cf-02e9-49c7-9803-887161e1989a7
40269624 HR felodipine 5 MG Extended Release Oral TabletSCD2e4298cf-02e9-49c7-9803-887161e1989a7
402695felodipine 10 MG 24 HR Extended Release Oral TabletSY2e4298cf-02e9-49c7-9803-887161e1989a7
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSY2e4298cf-02e9-49c7-9803-887161e1989a7
402696felodipine 5 MG 24 HR Extended Release Oral TabletSY2e4298cf-02e9-49c7-9803-887161e1989a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-235-0168462023501100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-235-01) 2010-12-200000-00-00NoNoCurrent
68462-235-10684620235101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-235-10) 2010-12-200000-00-00NoNoCurrent
68462-235-116846202351110 BLISTER PACK in 1 CARTON (68462-235-11) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2010-12-200000-00-00NoNoCurrent
68462-235-906846202359090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-235-90) 2010-12-200000-00-00NoNoCurrent