Home NDC 29300-359 Amiodarone Hydrochloride
Product NDC 29300-359
11-digit product format 293000359
Labeler code 29300
Product ID 29300-359_ca43a6d6-5537-4881-bf75-b43ade430dd1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
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 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 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 29300-359-05 Amiodarone Hydrochloride 500 in 1 BOTTLE TABLET 500 5 29300-359-16 Amiodarone Hydrochloride 60 in 1 BOTTLE TABLET 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29300-359 AMIODARONE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] 5 Current NDC, Legacy NDC, 2 package rows 20230224_a20d0c03-cfda-49d1-88c9-be1bf295bc6c.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 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 ndc (product): 29300-359
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 29300-359-05 29300035905 500 TABLET in 1 BOTTLE (29300-359-05) 500 tablet 2020-09-01 0000-00-00 No No Current 29300-359-16 29300035916 60 TABLET in 1 BOTTLE (29300-359-16) 60 tablet 2020-09-01 0000-00-00 No No Current