FDA.reportPublic FDA data

Application 022276

Type
NDA
Sponsor
EXELA PHARMA SCIENCE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEINJECTABLE;INJECTION25MG/10ML (2.5MG/ML)NoNo
002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENICARDIPINE HYDROCHLORIDEINJECTABLE;INTRAVENOUS20MG/200ML (0.1MG/ML)NoNo
003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENICARDIPINE HYDROCHLORIDEINJECTABLE;INTRAVENOUS40MG/200ML (0.2MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022276-001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24
N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENICARDIPINE HYDROCHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07
N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENICARDIPINE HYDROCHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N022276-001AP
N022276-002AP
N022276-003AP

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 22:54:322026-06N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24a50c72e98297…
2026-08-01 22:54:322026-06N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07a50c72e98297…
2026-08-01 22:54:322026-06N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022276-001AP1a50c72e98297…
2026-08-01 22:54:322026-06N022276-002AP1a50c72e98297…
2026-08-01 22:54:322026-06N022276-003AP1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9d898911-d811-2a78-e053-2995a90af7842025-01-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 022276
application number: NDA022276
ndc (product): 51662-1482
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.18fb1c2b-0c1e-436c-a5b6-d4840b5da2282024-08-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 022276
application number: NDA022276
ndc (product): 0143-9689
ndc (product): 0143-9634
ndc (product): 0143-9633
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.55bd6dcc-1f12-4378-8e9e-1ceed26818f52021-07-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 022276
application number: NDA022276
ndc (product): 0143-9542
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp0eb7d839-63d9-4b51-bf7b-4a8fde6339b52018-12-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 022276
application number: NDA022276
ndc (product): 0143-9593

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9542Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9542Nicardipine HydrochlorideNicardipine HydrochlorideWest-Ward Pharmaceuticals CorpNDACurrent
0143-9593Nicardipine HydrochlorideNicardipine HydrochlorideWest-Ward Pharmaceuticals CorpNDACurrent
0143-9633Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9633Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9634Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9634Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9689Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9689Nicardipine HydrochlorideNicardipine HydrochlorideWest-Ward Pharmaceuticals CorpNDACurrent
0143-9689Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
51662-1482NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1482NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82822SUPPL 2025-07-14
82821SUPPL 2025-07-14
80100SUPPL 2024-11-04
80099SUPPL 2024-11-04
69828SUPPL2022-01-11
69827SUPPL2022-01-11
67647SUPPL2021-06-01
65840SUPPL2021-01-07
53936ORIG2018-05-01
52436APPL2018-02-06
45417SUPPL2016-09-29
45394SUPPL2016-09-26
7159SUPPL2016-04-11
17187SUPPL2016-04-08
38486SUPPL2009-01-14
7158SUPPL2009-01-12
44724ORIG2008-10-09
21978ORIG2008-10-09
7157ORIG2008-07-31
17186ORIG2008-07-29