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 42.

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-241e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N022276-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N022276-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N022276-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022276-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022276-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022276-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022276-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022276-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022276-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022276-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022276-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022276-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022276-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022276-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022276-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022276-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022276-001AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022276-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022276-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022276-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022276-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022276-001AP19b2671bbb829…

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 · 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