Home NDC 71335-1942 Amiodarone Hydrochloride
Product NDC 71335-1942
11-digit product format 713351942
Labeler code 71335
Product ID 71335-1942_5b27ec4d-eebc-445d-a4ab-fced073afaa6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA213446
Marketing category ANDA
Marketing start 2020-09-01
Substance AMIODARONE HYDROCHLORIDE
Active strength 200 mg/1
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 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A213446-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213446-001 AB
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.
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 2026-02-19 14:30 UTC 2026-02 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213446-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-07-21 a50c72e98297…
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 200 mg/1
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 833528 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 71335-1942-1 Amiodarone Hydrochloride 200 in 1 BOTTLE TABLET 200 104 71335-1942-2 Amiodarone Hydrochloride 30 in 1 BOTTLE TABLET 30 104 71335-1942-3 Amiodarone Hydrochloride 60 in 1 BOTTLE TABLET 60 104 71335-1942-4 Amiodarone Hydrochloride 90 in 1 BOTTLE TABLET 90 104 71335-1942-5 Amiodarone Hydrochloride 10 in 1 BOTTLE TABLET 10 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1942 AMIODARONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 5 package rows 20241004_8377eb89-0d62-48c5-90e7-e96d545a4642.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. 4c149392-a4f0-4e2d-a13f-2b94810005de 2026-08-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213446 application number: ANDA213446 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Redpharm Drug 57f7f2ea-4ca9-4ada-e063-6294a90a492b 2026-08-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213446 application number: ANDA213446 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Bryant Ranch Prepack 8377eb89-0d62-48c5-90e7-e96d545a4642 2025-12-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213446 application number: ANDA213446 ndc (product): 71335-1942 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE A-S Medication Solutions c536e0ad-2758-4022-8242-f5e9b6aca1e2 2023-08-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213446 application number: ANDA213446 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Unichem Pharmaceuticals (USA), Inc. a20d0c03-cfda-49d1-88c9-be1bf295bc6c 2023-02-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213446 application number: ANDA213446
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 71335-1942-1 71335194201 200 TABLET in 1 BOTTLE (71335-1942-1) 200 tablet 2021-09-03 0000-00-00 No No Current 71335-1942-2 71335194202 30 TABLET in 1 BOTTLE (71335-1942-2) 30 tablet 2021-09-03 0000-00-00 No No Current 71335-1942-3 71335194203 60 TABLET in 1 BOTTLE (71335-1942-3) 60 tablet 2021-09-03 0000-00-00 No No Current 71335-1942-4 71335194204 90 TABLET in 1 BOTTLE (71335-1942-4) 90 tablet 2021-09-03 0000-00-00 No No Current 71335-1942-5 71335194205 10 TABLET in 1 BOTTLE (71335-1942-5) 10 tablet 2021-09-03 0000-00-00 No No Current