Home NDC 10122-314-10 Cardene IV
Product NDC 10122-314
Requested package NDC 10122-314-10
11-digit product format 101220314
Labeler code 10122
Product ID 10122-314_35a66ebb-329c-49ad-a047-9c0bf15e8028
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nicardipine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Chiesi USA, Inc.
Application NDA019734
Marketing category NDA
Marketing start 1992-01-30
Marketing end 2022-06-30
Substance NICARDIPINE HYDROCHLORIDE
Active strength 0 mg/mL
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019734-001 CARDENE NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1992-01-30 N019734-002 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2008-07-31 N019734-003 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-07-31 N019734-004 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-07 N019734-005 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS RLD 2008-11-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 22 matching rows.
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 6 · 215 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N019734-001 CARDENE 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1992-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019734-002 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2008-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019734-003 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019734-004 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019734-005 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS RLD 2008-11-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019734-001 CARDENE 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1992-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019734-002 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2008-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019734-003 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019734-004 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019734-005 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS RLD 2008-11-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019734-001 CARDENE 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1992-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019734-002 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2008-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019734-003 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019734-004 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019734-005 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS RLD 2008-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019734-001 CARDENE 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1992-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019734-002 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2008-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019734-003 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019734-004 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019734-005 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS RLD 2008-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019734-001 CARDENE 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1992-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019734-002 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2008-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019734-003 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019734-004 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019734-005 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS RLD 2008-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019734-001 CARDENE 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1992-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019734-002 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2008-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019734-003 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019734-004 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019734-005 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS RLD 2008-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019734-001 CARDENE 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1992-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019734-002 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2008-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019734-003 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019734-004 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019734-005 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS RLD 2008-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019734-001 CARDENE 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1992-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019734-002 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2008-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019734-003 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019734-004 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019734-005 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS RLD 2008-11-07 03ed91905a0d…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 22 · 880 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NICARDIPINE HYDROCHLORIDE ACTIVE INGREDIENT K5BC5011K3 CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] 6 NICARDIPINE ACTIVE MOIETY CZ5312222S CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] 6 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] 6 DEXTROSE MONOHYDRATE INACTIVE INGREDIENT LX22YL083G CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] 6 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] 6 SORBITOL INACTIVE INGREDIENT 506T60A25R CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.] 6
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10122-314-10 10122031410 10 CARTON in 1 BOX (10122-314-10) > 1 BAG in 1 CARTON (10122-314-01) > 200 mL in 1 BAG 10 carton 1992-01-30 2022-06-30 No No Current