FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
70069-875
11-digit product format
700690875
Labeler code
70069
Product ID
70069-875_035cb7ef-c5d5-4752-8d43-61b8e8420330
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA220243
Marketing category
ANDA
Marketing start
2026-04-20
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
2026-08-18 06:07:402026-07A220243-001NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAP2025-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A220243-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAP2025-10-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220243-001NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAP2025-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A220243-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAP2025-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220243-001NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAP2025-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220243-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAP2025-10-2231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220243-001NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAP2025-10-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220243-002NICARDIPINE 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
2026-08-18 06:07:402026-07A220243-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220243-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220243-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A220243-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220243-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220243-002AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220243-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220243-002AP1a50c72e98297…

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
f8b49f59-7a54-425d-9eca-dfa4022a08d1Available 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
70069-875-01Nicardipine Hydrochloride200 mL in 1 BAGINJECTION2002
70069-875-01Nicardipine Hydrochloride1 in 1 POUCHINJECTION12
70069-875-10Nicardipine Hydrochloride10 in 1 CASEINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-875-01ML - Milliliter70069-875501832ba-a08e-4f73-a746-559ee030ef9712026-05-22
70069-875-10ML - Milliliter70069-875755aa2f0-a16f-4d83-a5b6-d934e6aa5ece12026-05-22

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDESomerset Therapeutics, LLCf8b49f59-7a54-425d-9eca-dfa4022a08d12026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220243
application number: ANDA220243
ndc (product): 70069-875

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858599niCARdipine HCl 20 MG in 200 ML InjectionPSNf8b49f59-7a54-425d-9eca-dfa4022a08d12
858603niCARdipine HCl 40 MG in 200 ML InjectionPSNf8b49f59-7a54-425d-9eca-dfa4022a08d12
858599200 ML nicardipine hydrochloride 0.1 MG/ML InjectionSCDf8b49f59-7a54-425d-9eca-dfa4022a08d12
858603200 ML nicardipine hydrochloride 0.2 MG/ML InjectionSCDf8b49f59-7a54-425d-9eca-dfa4022a08d12
858599nicardipine hydrochloride 20 MG per 200 ML InjectionSYf8b49f59-7a54-425d-9eca-dfa4022a08d12
858603nicardipine hydrochloride 40 MG per 200 ML InjectionSYf8b49f59-7a54-425d-9eca-dfa4022a08d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-875-0170069087501200 mL in 1 BAG200 mlHistorical
70069-875-107006908751010 POUCH in 1 CASE (70069-875-10) / 1 BAG in 1 POUCH (70069-875-01) / 200 mL in 1 BAG10 pouch2026-04-20NoNoCurrent