AMIODARONE HYDROCHLORIDE
- Product NDC
- 68084-371
- 11-digit product format
- 680840371
- Labeler code
- 68084
- Product ID
- 68084-371_a6286918-2fde-be5e-e053-2a95a90a6bb9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMIODARONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA079029
- Marketing category
- ANDA
- Marketing start
- 2009-09-10
- Marketing end
- 2020-10-31
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68084-371 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 68084-371 | 68084-371-01 | D | Discontinued by firm | 2026-08-17 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68084-371-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68084-371-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68084-371-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68084-371-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68084-371-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68084-371-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68084-371-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68084-371-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68084-371-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68084-371-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68084-371-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68084-371-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A079029-001 | AB |
| A079029-002 | AB |
| A079029-003 | AB |
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.
| 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#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A079029-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079029-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079029-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A079029-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079029-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079029-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079029-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079029-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079029-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A079029-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079029-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079029-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079029-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079029-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079029-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079029-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079029-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079029-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079029-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079029-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079029-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079029-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079029-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079029-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079029-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079029-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079029-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079029-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079029-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079029-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A079029-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A079029-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A079029-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079029-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079029-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079029-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079029-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079029-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079029-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079029-001 | AB | 1 | 1e350fbaab3a… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68084-371-01 | EA - Each | 68084-371 | 4b36498c-3a86-4235-81ba-832725878dcc | 1 | 2012-07-24 |
| 68084-371-11 | EA - Each | 68084-371 | e7cd2c74-0d7f-401c-9792-6b461c9b04ef | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| amiodarone hydrochloride | AMIODARONE HYDROCHLORIDE | Safecor Health LLC | f49d011f-5ca6-4f75-ba16-2099fe42f5aa | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 079029 ANDA079029 |
| Amiodarone hydrochloride | AMIODARONE HYDROCHLORIDE | Zydus Lifesciences Limited | 3e8db251-e3c5-4fba-be9a-6044a92f0beb | 2024-11-25 | 079029 ANDA079029 | |
| amiodarone hydrochloride | AMIODARONE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | b41cbcb5-9c5d-4e45-a4f2-952df5f22c00 | 2023-03-16 | Boxed warning, Warnings, Adverse reactions | 079029 ANDA079029 |