Home NDC 43066-029-10 CARDENE IV
Product NDC 43066-029
Requested package NDC 43066-029-10
11-digit product format 430660029
Labeler code 43066
Product ID 43066-029_5749599d-ff2a-42e4-aa72-cd25013feee8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nicardipine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA019734
Marketing category NDA
Marketing start 1992-01-30
Substance NICARDIPINE HYDROCHLORIDE
Active strength 2.5 mg/10mL
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 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NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1992-01-30 N019734-002 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER NICARDIPINE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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CARDENE IV
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICARDIPINE HYDROCHLORIDE 2.5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K5BC5011K3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858607 Internal RxNorm lookup 858609 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43066-029-01 CARDENE IV 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 1 43066-029-10 CARDENE IV 10 in 1 CARTON INJECTION, SOLUTION 10 1
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 Marketing start Sample Exclude flag Status 43066-029-10 43066002910 10 VIAL, SINGLE-DOSE in 1 CARTON (43066-029-10) / 10 mL in 1 VIAL, SINGLE-DOSE (43066-029-01) 2025-12-29 No No Current