Home NDC 63629-2076-1 Amiodarone HCl
Product NDC 63629-2076
Requested package NDC 63629-2076-1
11-digit product format 636292076
Labeler code 63629
Product ID 63629-2076_b7acb460-a87d-43f9-b48c-7dc407390c26
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA077069
Marketing category ANDA
Marketing start 2017-01-01
Marketing end 0000-00-00
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 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 A077069-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 A077069-002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 A077069-003 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04
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 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077069-002 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2005-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077069-003 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2016-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077069-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2005-04-08 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-2076-1 63629207601 30 TABLET in 1 BOTTLE (63629-2076-1) 30 tablet 2022-02-08 0000-00-00 No No Current