Nicardipine Hydrochloride

Product NDC
0378-1430
11-digit product format
003781430
Labeler code
0378
Product ID
0378-1430_f485be32-7e98-4046-a125-b5453c3c2c74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074642
Marketing category
ANDA
Marketing start
1996-07-19
Marketing end
2030-01-31
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-1430DDiscontinued by firm2026-08-03
excluded packagepackage0378-14300378-1430-05DDiscontinued by firm2026-08-03
excluded packagepackage0378-14300378-1430-77DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 21 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct0378-1430DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-14300378-1430-05DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-14300378-1430-77DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct0378-1430DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-14300378-1430-05DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-14300378-1430-77DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct0378-1430DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-14300378-1430-05DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-14300378-1430-77DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0378-1430DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-14300378-1430-05DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-14300378-1430-77DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct0378-1430DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-14300378-1430-05DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-14300378-1430-77DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct0378-1430DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-14300378-1430-05DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-14300378-1430-77DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct0378-1430DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-14300378-1430-05DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-14300378-1430-77DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074642-001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-18
A074642-002NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-18

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1996-07-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1996-07-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074642-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL1996-07-18782e0a99824c…
2021-12-28 21:50 UTC2021-12A074642-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL1996-07-18782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A074642-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074642-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A074642-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A074642-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074642-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074642-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074642-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074642-002AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31746078-c5c3-4387-a2ed-bd3c8b244c53Product name220250325
037c6bd8-1c81-7b8c-8280-c83d993a1f03Product name220250203
c9eb0343-053f-7f78-730f-1be02ab91c6cProduct name520250130

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1430-05EA - Each0378-143017141ffc-6e0d-40eb-8487-10c17e31446712012-07-24
0378-1430-77EA - Each0378-143017bf838f-ea6e-4ab2-ac22-0c6cbac7a2d312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
NICARDIPINEACTIVE MOIETYCZ5312222SNICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SNICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
GELATININACTIVE INGREDIENT2G86QN327LNICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
NICARDIPINEACTIVE MOIETYCZ5312222SNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858616niCARdipine HCl 30 MG Oral CapsulePSN0555647b-1a62-48b8-8821-ef38b996efb74
858616nicardipine hydrochloride 30 MG Oral CapsuleSCD0555647b-1a62-48b8-8821-ef38b996efb74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1430-0500378143005500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1430-05) 500 capsule1996-07-190000-00-00NoNoCurrent
0378-1430-770037814307790 CAPSULE in 1 BOTTLE, PLASTIC (0378-1430-77) 90 capsule1996-07-190000-00-00NoNoCurrent