Home NDC 50268-097 Amiodarone Hydrochloride
Product NDC 50268-097
11-digit product format 502680097
Labeler code 50268
Product ID 50268-097_47e23673-1380-50b5-e063-6394a90a9314
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler AvPAK
Application ANDA075389
Marketing category ANDA
Marketing start 2019-09-11
Substance AMIODARONE HYDROCHLORIDE
Active strength 100 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 A075389-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 A075389-002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 A075389-003 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28
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 4 · 126 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 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 100 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 835956 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 50268-097-11 Amiodarone Hydrochloride 1 in 1 BLISTER PACK TABLET 1 5 50268-097-15 Amiodarone Hydrochloride 50 in 1 BOX TABLET 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-097 AMIODARONE HYDROCHLORIDE TABLET [AVPAK] 4 Current NDC, Legacy NDC, 2 package rows 20241010_924c9359-ebc4-62a7-e053-2a95a90a4327.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 · 2 matching rows.
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 50268-097-11 50268009711 1 in 1 BLISTER PACK Historical 50268-097-15 50268009715 50 BLISTER PACK in 1 BOX (50268-097-15) / 1 TABLET in 1 BLISTER PACK (50268-097-11) 50 blister pack 2019-09-11 0000-00-00 No No Current