FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
24658-750
11-digit product format
246580750
Labeler code
24658
Product ID
24658-750_69c60be8-143d-4a50-8a66-46c01c416372
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PuraCap Laboratories LLC dba Blu Pharmaceuticals
Application
ANDA074928
Marketing category
ANDA
Marketing start
2016-12-15
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
20 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
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEPuraCap Laboratories LLC dba Blu Pharmaceuticals065efabf-8c7d-4dd5-aef2-700c2eca399d2019-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074928
application number: ANDA074928
ndc (product): 24658-750

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE20 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
065efabf-8c7d-4dd5-aef2-700c2eca399dAvailable 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
24658-750-90Nicardipine Hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-750-90EA - Each24658-750a86acd54-617d-4d71-8151-33bf436e67e312017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-750NICARDIPINE HYDROCHLORIDE CAPSULE [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]5Current NDC, Legacy NDC, 1 package rows20190108_065efabf-8c7d-4dd5-aef2-700c2eca399d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSN065efabf-8c7d-4dd5-aef2-700c2eca399d5
858616niCARdipine HCl 30 MG Oral CapsulePSN065efabf-8c7d-4dd5-aef2-700c2eca399d5
858613nicardipine hydrochloride 20 MG Oral CapsuleSCD065efabf-8c7d-4dd5-aef2-700c2eca399d5
858616nicardipine hydrochloride 30 MG Oral CapsuleSCD065efabf-8c7d-4dd5-aef2-700c2eca399d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24658-750-902465807509090 CAPSULE in 1 BOTTLE (24658-750-90) 90 capsule2016-12-150000-00-00NoNoCurrent