Home NDC 70518-1231 Amiodarone Hydrochloride
Product NDC 70518-1231
11-digit product format 705181231
Labeler code 70518
Product ID 70518-1231_48c17e3b-f248-1cef-e063-6294a90a467b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler REMEDYREPACK INC.
Application ANDA077234
Marketing category ANDA
Marketing start 2018-05-30
Substance AMIODARONE HYDROCHLORIDE
Active strength 50 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 2027-12-31
Current FDA listing Yes 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, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-1231-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-1231-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-1231-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-1231-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-1231-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-1231-1 557ba5c1ecfa…9c80585c8c6e…
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 A077234-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077234-001 AP
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 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Amiodarone Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMIODARONE HYDROCHLORIDE 50 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1663224 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 70518-1231-0 Amiodarone Hydrochloride 3 mL in 1 VIAL INJECTION, SOLUTION 3 11 70518-1231-1 Amiodarone Hydrochloride 25 in 1 BOX INJECTION, SOLUTION 25 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-1231 AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [REMEDYREPACK INC.] 8 Current NDC, Legacy NDC, 2 package rows 20250509_e9151c1b-b70c-477b-868a-fffdc5c51830.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE REMEDYREPACK INC. e9151c1b-b70c-477b-868a-fffdc5c51830 2026-01-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077234 application number: ANDA077234 ndc (product): 70518-1231 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE Henry Schein, Inc. 0c9ee15a-5741-4aaa-8d80-c7bd2e45822e 2025-10-29 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077234 application number: ANDA077234 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 51772745-9ea9-42cd-97e6-7266f41ae3ca 2024-04-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077234 application number: ANDA077234 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 7639dfe4-933c-2916-e053-2a91aa0a3fe7 2024-02-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077234 application number: ANDA077234 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Medical Purchasing Solutions, LLC 66700f8b-3f76-3749-e053-2a91aa0adfdb 2023-04-18 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077234 application number: ANDA077234
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 70518-1231-0 70518123100 3 mL in 1 VIAL 3 ml Historical 70518-1231-1 70518123101 25 VIAL in 1 BOX (70518-1231-1) / 3 mL in 1 VIAL (70518-1231-0) 25 vial 2018-05-30 0000-00-00 No No Current