Home NDC 0904-6993 Amiodarone Hydrochloride
Product NDC 0904-6993
11-digit product format 009046993
Labeler code 0904
Product ID 0904-6993_64f4746d-7518-4865-a7e4-8c3f17ace734
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA075424
Marketing category ANDA
Marketing start 2001-03-30
Marketing end 2027-01-31
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
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 · 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 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 0904-6993-61 Amiodarone Hydrochloride 1 in 1 BLISTER PACK TABLET 1 7 0904-6993-61 Amiodarone Hydrochloride 100 in 1 CARTON TABLET 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6993 AMIODARONE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 Current NDC, Legacy NDC, 2 package rows 20250524_352ed423-fc16-47bb-8e25-98e1c20f9991.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 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 ndc (product): 0904-6993 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 0904-6993-61 00904699361 100 BLISTER PACK in 1 CARTON (0904-6993-61) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2020-04-20 2027-01-31 No No Current