FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
42806-502
11-digit product format
428060502
Labeler code
42806
Product ID
42806-502_cdaf4385-811f-4e33-9990-b4e2586b81b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA074928
Marketing category
ANDA
Marketing start
2010-05-05
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [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 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
A074928-001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19
A074928-002NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074928-001AB
A074928-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19a50c72e98297…
2026-08-01 22:54:322026-06A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074928-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A074928-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEEpic Pharma, LLCb8f147b8-955f-4733-9178-2cfa0beb60d62023-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074928
application number: ANDA074928
ndc (product): 42806-502
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEPuraCap Laboratories LLC dba Blu Pharmaceuticals065efabf-8c7d-4dd5-aef2-700c2eca399d2019-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074928
application number: ANDA074928

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K5BC5011K3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858613Internal RxNorm lookup
858616Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8f147b8-955f-4733-9178-2cfa0beb60d6Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-502-01Nicardipine Hydrochloride100 in 1 BOTTLECAPSULE10010
42806-502-05Nicardipine Hydrochloride500 in 1 BOTTLECAPSULE50010
42806-502-09Nicardipine Hydrochloride90 in 1 BOTTLECAPSULE9010
42806-502-10Nicardipine Hydrochloride1000 in 1 BOTTLECAPSULE100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-502-01EA - Each42806-502aba77c0b-2250-452a-aee1-a9a49a8f300512012-07-24
42806-502-05EA - Each42806-50226013a8c-cfa1-4666-859d-173b13ee804d12012-07-24
42806-502-09EA - Each42806-5025c0f9f80-d9b1-4fa0-9836-05af88c5e3bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6
NICARDIPINEACTIVE MOIETYCZ5312222SNICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6
GELATININACTIVE INGREDIENT2G86QN327LNICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-502NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]10Current NDC, Legacy NDC, 4 package rows20231228_b8f147b8-955f-4733-9178-2cfa0beb60d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSNb8f147b8-955f-4733-9178-2cfa0beb60d610
858616niCARdipine HCl 30 MG Oral CapsulePSNb8f147b8-955f-4733-9178-2cfa0beb60d610
858613nicardipine hydrochloride 20 MG Oral CapsuleSCDb8f147b8-955f-4733-9178-2cfa0beb60d610
858616nicardipine hydrochloride 30 MG Oral CapsuleSCDb8f147b8-955f-4733-9178-2cfa0beb60d610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-502-0142806050201100 CAPSULE in 1 BOTTLE (42806-502-01) 100 capsule2010-05-050000-00-00NoNoCurrent
42806-502-0542806050205500 CAPSULE in 1 BOTTLE (42806-502-05) 500 capsule2010-05-050000-00-00NoNoCurrent
42806-502-094280605020990 CAPSULE in 1 BOTTLE (42806-502-09) 90 capsule2010-05-050000-00-00NoNoCurrent
42806-502-10428060502101000 CAPSULE in 1 BOTTLE (42806-502-10) 1000 capsule2010-05-050000-00-00NoNoCurrent