Home NDC 68382-298 amiodarone hydrochloride
Product NDC 68382-298
11-digit product format 683820298
Labeler code 68382
Product ID 68382-298_b3f11ad6-9f3b-4054-9c51-3d2614c1002e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amiodarone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA079029
Marketing category ANDA
Marketing start 2023-02-09
Substance AMIODARONE HYDROCHLORIDE
Active strength 400 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 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 A079029-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 A079029-002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 A079029-003 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06
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 · 92 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 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079029-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-01-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079029-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-01-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079029-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2008-09-16 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 observed states.
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 400 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 833528 Internal RxNorm lookup 834348 Internal RxNorm lookup 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 68382-298-06 amiodarone hydrochloride 30 in 1 BOTTLE TABLET 30 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-298 AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS USA INC.] 19 Current NDC, 1 package rows 20230317_b41cbcb5-9c5d-4e45-a4f2-952df5f22c00.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68382-298-06 68382029806 30 TABLET in 1 BOTTLE (68382-298-06) 30 tablet 2023-02-09 No No Current