Home NDC 71335-1985 Amiodarone Hydrochloride
Product NDC 71335-1985
11-digit product format 713351985
Labeler code 71335
Product ID 71335-1985_b7d415a2-bf21-4d6c-8f01-e1e22a539e42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA078578
Marketing category ANDA
Marketing start 2020-03-09
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 2027-12-31
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 A078578-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 A078578-002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 A078578-003 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 3 · 112 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 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078578-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-02-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078578-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078578-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-11-06 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 112 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 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 71335-1985-1 Amiodarone Hydrochloride 200 in 1 BOTTLE TABLET 200 103 71335-1985-2 Amiodarone Hydrochloride 30 in 1 BOTTLE TABLET 30 103 71335-1985-3 Amiodarone Hydrochloride 60 in 1 BOTTLE TABLET 60 103 71335-1985-4 Amiodarone Hydrochloride 90 in 1 BOTTLE TABLET 90 103 71335-1985-5 Amiodarone Hydrochloride 10 in 1 BOTTLE TABLET 10 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1985 AMIODARONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 5 package rows 20231118_f4532f12-3b7a-42ab-9a6c-36fd2a3f192c.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 Bryant Ranch Prepack f4532f12-3b7a-42ab-9a6c-36fd2a3f192c 2026-05-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078578 application number: ANDA078578 ndc (product): 71335-1985 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Major Pharmaceuticals b8bf4aa2-abea-403d-a6d9-395caf5f87f0 2026-05-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078578 application number: ANDA078578 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE REMEDYREPACK INC. 337c5695-e3f8-41c6-a088-a492d5c60215 2026-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078578 application number: ANDA078578 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE NCS HealthCare of KY, LLC dba Vangard Labs 28cd0224-3569-4308-bd40-480bc4230503 2025-12-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078578 application number: ANDA078578 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Advagen Pharma Limited d911b4cf-eec4-43f8-aa64-cc60cfc901b9 2025-12-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078578 application number: ANDA078578
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 71335-1985-1 71335198501 200 TABLET in 1 BOTTLE (71335-1985-1) 200 tablet 2022-10-13 0000-00-00 No No Current 71335-1985-2 71335198502 30 TABLET in 1 BOTTLE (71335-1985-2) 30 tablet 2022-10-13 0000-00-00 No No Current 71335-1985-3 71335198503 60 TABLET in 1 BOTTLE (71335-1985-3) 60 tablet 2022-10-13 0000-00-00 No No Current 71335-1985-4 71335198504 90 TABLET in 1 BOTTLE (71335-1985-4) 90 tablet 2021-10-29 0000-00-00 No No Current 71335-1985-5 71335198505 10 TABLET in 1 BOTTLE (71335-1985-5) 10 tablet 2022-10-13 0000-00-00 No No Current