Home NDC 51662-1481 NEXTERONE (AMIODARONE HCI)
Product NDC 51662-1481
11-digit product format 516621481
Labeler code 51662
Product ID 51662-1481_11c3bf02-6616-9353-e063-6394a90af9cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NEXTERONE (AMIODARONE HCI)
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application NDA022325
Marketing category NDA
Marketing start 2020-01-29
Substance AMIODARONE HYDROCHLORIDE
Active strength 1.8 mg/mL
Pharmacologic classes Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022325-001 NEXTERONE AMIODARONE HYDROCHLORIDE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 N022325-002 NEXTERONE AMIODARONE HYDROCHLORIDE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 N022325-003 NEXTERONE AMIODARONE HYDROCHLORIDE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022325-001 7635773 2029-03-13 Drug product N022325-002 10117951 2029-03-13 Drug product 2026-06-03 N022325-002 7635773 2029-03-13 Drug product N022325-002 8410077 2029-03-13 Drug product 2026-04-21 N022325-002 9200088 2029-03-13 Drug product 2026-04-21 N022325-002 9750822 2029-03-13 Drug product 2026-04-21 N022325-002 9493582 2033-02-27 Drug product 2026-04-21 N022325-003 10117951 2029-03-13 Drug product 2026-06-03 N022325-003 7635773 2029-03-13 Drug product N022325-003 8410077 2029-03-13 Drug product 2026-04-21 N022325-003 9200088 2029-03-13 Drug product 2026-04-21 N022325-003 9750822 2029-03-13 Drug product 2026-04-21 N022325-003 9493582 2033-02-27 Drug product 2026-04-21
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022325-002 NEXTERONE 150MG/100ML (1.5MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022325-003 NEXTERONE 360MG/200ML (1.8MG/ML) INJECTABLE / INJECTION RLD, RS 2010-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022325-001 NEXTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2008-12-24 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 5 · 200 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022325-001 7635773 2029-03-13 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-002 10117951 2029-03-13 Drug product 2026-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-002 7635773 2029-03-13 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-002 8410077 2029-03-13 Drug product 2026-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-002 9200088 2029-03-13 Drug product 2026-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-002 9750822 2029-03-13 Drug product 2026-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-002 9493582 2033-02-27 Drug product 2026-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-003 10117951 2029-03-13 Drug product 2026-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-003 7635773 2029-03-13 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-003 8410077 2029-03-13 Drug product 2026-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-003 9200088 2029-03-13 Drug product 2026-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-003 9750822 2029-03-13 Drug product 2026-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022325-003 9493582 2033-02-27 Drug product 2026-04-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022325-001 7635773 2029-03-13 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022325-002 7635773 2029-03-13 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022325-003 7635773 2029-03-13 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022325-001 7635773 2029-03-13 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022325-002 7635773 2029-03-13 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022325-003 7635773 2029-03-13 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022325-001 7635773 2029-03-13 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022325-002 7635773 2029-03-13 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022325-003 7635773 2029-03-13 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022325-001 7635773 2029-03-13 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022325-002 7635773 2029-03-13 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022325-003 7635773 2029-03-13 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022325-001 7635773 2029-03-13 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022325-002 7635773 2029-03-13 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022325-003 7635773 2029-03-13 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022325-001 7635773 2029-03-13 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022325-002 7635773 2029-03-13 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022325-003 7635773 2029-03-13 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022325-001 7635773 2029-03-13 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022325-002 7635773 2029-03-13 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022325-003 7635773 2029-03-13 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022325-001 7635773 2029-03-13 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022325-002 7635773 2029-03-13 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022325-003 7635773 2029-03-13 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022325-001 7635773 2029-03-13 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022325-002 7635773 2029-03-13 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022325-003 7635773 2029-03-13 Drug product d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base NEXTERONE (AMIODARONE HCI)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMIODARONE HYDROCHLORIDE 1.8 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 976728SY6Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849876 Internal RxNorm lookup 1046406 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 51662-1481-1 NEXTERONE (AMIODARONE HCI) 1 in 1 CARTON INJECTION, SOLUTION 1 3 51662-1481-1 NEXTERONE (AMIODARONE HCI) 200 mL in 1 BAG INJECTION, SOLUTION 200 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1481 NEXTERONE (AMIODARONE HCI) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 3 Current NDC, Legacy NDC, 2 package rows 20240220_9d4d66f7-fa14-e832-e053-2a95a90a8b62.zip
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.
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 51662-1481-1 51662148101 1 BAG in 1 CARTON (51662-1481-1) / 200 mL in 1 BAG 1 bag 2020-01-29 0000-00-00 No No Current