Nicardipine Hydrochloride

Product NDC
24658-751
11-digit product format
246580751
Labeler code
24658
Product ID
24658-751_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
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.

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 UTC2026-02A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB1998-03-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074928-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB1998-03-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A074928-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALABRS1998-03-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074928-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074928-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074928-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074928-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074928-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074928-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074928-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074928-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074928-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074928-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074928-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074928-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074928-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074928-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074928-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074928-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074928-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074928-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074928-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074928-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074928-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074928-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074928-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074928-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074928-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074928-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074928-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074928-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074928-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074928-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074928-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074928-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074928-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074928-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074928-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074928-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074928-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074928-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074928-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074928-002AB1782e0a99824c…

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): 24658-751

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
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
24658-751-90Nicardipine Hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-751-90EA - Each24658-7511cea1c2f-0350-4da0-a8f9-0a3490a520c912017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-751NICARDIPINE 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
24658-751-902465807519090 CAPSULE in 1 BOTTLE (24658-751-90) 90 capsule2016-12-150000-00-00NoNoCurrent