FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
65145-197
11-digit product format
651450197
Labeler code
65145
Product ID
65145-197_9383f1dc-0310-4c87-a8f0-48c09a85d89b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA220243
Marketing category
ANDA
Marketing start
2025-11-04
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
.1 mg/mL
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
A220243-001NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENICARDIPINE HYDROCHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAP2025-10-22
A220243-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENICARDIPINE HYDROCHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAP2025-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220243-001AP
A220243-002AP

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 22:54:322026-06A220243-001NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAP2025-10-22a50c72e98297…
2026-08-01 22:54:322026-06A220243-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAP2025-10-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A220243-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A220243-002AP1a50c72e98297…

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 HYDROCHLORIDECaplin Steriles Limited9383f1dc-0310-4c87-a8f0-48c09a85d89b2026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220243
application number: ANDA220243
ndc (product): 65145-197
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDESomerset Therapeutics, LLCf8b49f59-7a54-425d-9eca-dfa4022a08d12026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220243
application number: ANDA220243

Additional Listing Data#

Finished product
Yes
Brand name base
Nicardipine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE.1 mg/mL

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
858599Internal RxNorm lookup
858603Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9383f1dc-0310-4c87-a8f0-48c09a85d89bAvailable 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
65145-197-01Nicardipine Hydrochloride200 mL in 1 BAGINJECTION2001
65145-197-01Nicardipine Hydrochloride1 in 1 POUCHINJECTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858599niCARdipine HCl 20 MG in 200 ML InjectionPSN9383f1dc-0310-4c87-a8f0-48c09a85d89b1
858603niCARdipine HCl 40 MG in 200 ML InjectionPSN9383f1dc-0310-4c87-a8f0-48c09a85d89b1
858599200 ML nicardipine hydrochloride 0.1 MG/ML InjectionSCD9383f1dc-0310-4c87-a8f0-48c09a85d89b1
858603200 ML nicardipine hydrochloride 0.2 MG/ML InjectionSCD9383f1dc-0310-4c87-a8f0-48c09a85d89b1
858599nicardipine hydrochloride 20 MG per 200 ML InjectionSY9383f1dc-0310-4c87-a8f0-48c09a85d89b1
858603nicardipine hydrochloride 40 MG per 200 ML InjectionSY9383f1dc-0310-4c87-a8f0-48c09a85d89b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-197-01651450197011 BAG in 1 POUCH (65145-197-01) / 200 mL in 1 BAG1 bag2025-11-04NoNoHistorical
65145-197-106514501971010 POUCH in 1 CASE (65145-197-10) / 1 BAG in 1 POUCH (65145-197-01) / 200 mL in 1 BAG10 pouch2026-06-250Current