Nicardipine hydrochloride

Product NDC
69238-2692
11-digit product format
692382692
Labeler code
69238
Product ID
69238-2692_8f57d96f-7e5b-409f-9e21-c3ed67369716
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA218202
Marketing category
ANDA
Marketing start
2024-10-03
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
A218202-001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-10
A218202-002NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218202-001AB
A218202-002AB

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
2026-02-19 14:30 UTC2026-02A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-108072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218202-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2024-04-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218202-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2024-04-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218202-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218202-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218202-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218202-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218202-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218202-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218202-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218202-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218202-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218202-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218202-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218202-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218202-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218202-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218202-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218202-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218202-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218202-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218202-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A218202-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218202-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218202-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218202-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218202-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218202-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218202-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218202-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A218202-002AB18072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218202-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218202-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicardipine hydrochlorideNICARDIPINEAmneal Pharmaceuticals NY LLC79304b0f-53d3-4065-8c81-7031d11416942024-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218202
application number: ANDA218202
ndc (product): 69238-2692

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
79304b0f-53d3-4065-8c81-7031d1141694Available 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
69238-2692-1Nicardipine hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2692-1EA - Each69238-26926e9ed503-c6ae-487a-9909-91a10e4f49a412025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2692NICARDIPINE HYDROCHLORIDE (NICARDIPINE) CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]1Current NDC, 1 package rows20241004_79304b0f-53d3-4065-8c81-7031d1141694.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSN79304b0f-53d3-4065-8c81-7031d11416941
858616niCARdipine HCl 30 MG Oral CapsulePSN79304b0f-53d3-4065-8c81-7031d11416941
858613nicardipine hydrochloride 20 MG Oral CapsuleSCD79304b0f-53d3-4065-8c81-7031d11416941
858616nicardipine hydrochloride 30 MG Oral CapsuleSCD79304b0f-53d3-4065-8c81-7031d11416941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2692-16923826920190 CAPSULE in 1 BOTTLE (69238-2692-1) 90 capsule2024-10-03NoNoCurrent