Home NDC 55150-180 Amiodarone Hydrochloride
Product NDC 55150-180
11-digit product format 551500180
Labeler code 55150
Product ID 55150-180_c2e4f552-4ed1-4c8c-b865-39596b79b1ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler AuroMedics Pharma LLC
Application ANDA204550
Marketing category ANDA
Marketing start 2017-10-25
Substance AMIODARONE HYDROCHLORIDE
Active strength 150 mg/3mL
Pharmacologic classes Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204550-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25
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 2 · 42 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 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2017-10-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204550-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2017-10-25 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Amiodarone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMIODARONE HYDROCHLORIDE 150 mg/3mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 833532 Internal RxNorm lookup 1663224 Internal RxNorm lookup 1663244 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 55150-180-03 Amiodarone Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 2 55150-180-03 Amiodarone Hydrochloride 3 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-180 AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] 2 Current NDC, Legacy NDC, 2 package rows 20211212_6cd870d7-6381-421a-89bc-bce5c9518219.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 Marketing start Marketing end Sample Exclude flag Status 55150-180-03 55150018003 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-180-03) / 3 mL in 1 VIAL, SINGLE-DOSE 2017-10-25 0000-00-00 No No Current