Amiodarone hydrochloride
- Product NDC
- 63739-051
- 11-digit product format
- 637390051
- Labeler code
- 63739
- Product ID
- 63739-051_bd9cb250-28d4-0e82-e053-2a95a90a2936
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- McKesson Corporation dba SKY Packaging
- Application
- ANDA079029
- Marketing category
- ANDA
- Marketing start
- 2009-08-10
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- 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 | 63739-051 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 63739-051 | 63739-051-10 | D | Discontinued by firm | 2026-08-17 |
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… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63739-051-10 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-26c6-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63739-051-10 | EA - Each | 63739-051 | f5db1340-f0a8-4c56-8414-a299c6d44bd7 | 1 | 2020-03-10 |
DailyMed Dashboard NDC Coverage#
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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63739-051-10 | 63739005110 | 10 BLISTER PACK in 1 BOX (63739-051-10) > 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2019-12-06 | 0000-00-00 | No | No | Current |