Home NDC 71335-0881 Amiodarone Hydrochloride
Product NDC 71335-0881
11-digit product format 713350881
Labeler code 71335
Product ID 71335-0881_a148ddb8-adb0-46dc-90ed-7df37af2a4ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075424
Marketing category ANDA
Marketing start 2001-03-30
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075424-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 A075424-002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 84 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 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2001-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075424-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075424-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-12-18 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-0881-1 2024-05-21 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-1 2024-05-21 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-2 2024-05-21 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-2 2024-05-21 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-3 2024-05-21 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-3 2024-05-21 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-4 2024-05-21 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-4 2024-05-21 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-5 2024-05-21 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-5 2024-05-21 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-1 2024-01-30 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-1 2024-01-30 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-2 2024-01-30 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-2 2024-01-30 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-3 2024-01-30 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-3 2024-01-30 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-4 2024-01-30 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-4 2024-01-30 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-5 2024-01-30 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0881-5 2024-01-30 These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-0881-1 Amiodarone Hydrochloride 200 in 1 BOTTLE TABLET 200 5 71335-0881-2 Amiodarone Hydrochloride 30 in 1 BOTTLE TABLET 30 5 71335-0881-3 Amiodarone Hydrochloride 60 in 1 BOTTLE TABLET 60 5 71335-0881-4 Amiodarone Hydrochloride 90 in 1 BOTTLE TABLET 90 5 71335-0881-5 Amiodarone Hydrochloride 10 in 1 BOTTLE TABLET 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0881 AMIODARONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 5 Current NDC, Legacy NDC, 5 package rows 20240522_f3e631c5-1204-419c-8dbe-fa9b37a77f97.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 · 4 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 f3e631c5-1204-419c-8dbe-fa9b37a77f97 2026-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075424 application number: ANDA075424 ndc (product): 71335-0881 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Cardinal Health 107, LLC 7bdc2236-3a1a-4210-a9fb-38f860227aa7 2026-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075424 application number: ANDA075424 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Major Pharmaceuticals 352ed423-fc16-47bb-8e25-98e1c20f9991 2026-03-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075424 application number: ANDA075424 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Sun Pharmaceutical Industries, Inc. 7ccd3733-c3af-4a11-8500-0f99194c1472 2026-03-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075424 application number: ANDA075424
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 71335-0881-1 71335088101 200 TABLET in 1 BOTTLE (71335-0881-1) 200 tablet 2021-12-27 0000-00-00 No No Current 71335-0881-2 71335088102 30 TABLET in 1 BOTTLE (71335-0881-2) 30 tablet 2019-01-03 0000-00-00 No No Current 71335-0881-3 71335088103 60 TABLET in 1 BOTTLE (71335-0881-3) 60 tablet 2021-12-27 0000-00-00 No No Current 71335-0881-4 71335088104 90 TABLET in 1 BOTTLE (71335-0881-4) 90 tablet 2018-06-26 0000-00-00 No No Current 71335-0881-5 71335088105 10 TABLET in 1 BOTTLE (71335-0881-5) 10 tablet 2021-12-27 0000-00-00 No No Current