Amiodarone Hydrochloride

Product NDC
51862-242
11-digit product format
518620242
Labeler code
51862
Product ID
51862-242_d1f528b3-67b2-49b5-8f63-3933615a257f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA075389
Marketing category
ANDA
Marketing start
2018-01-02
Marketing end
0000-00-00
Substance
AMIODARONE HYDROCHLORIDE
Active strength
400 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
2021-12-31
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51862-242DDiscontinued by firm2026-08-17
excluded packagepackage51862-24251862-242-30DDiscontinued by firm2026-08-17

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.

Historic NDC status page 1 of 1 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51862-242-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51862-242-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51862-242-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51862-242-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51862-242-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51862-242-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51862-242-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51862-242-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51862-242-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51862-242-30ad56d346431e…cc804d4bbf1e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075389-001AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-25
A075389-002AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-28
A075389-003AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075389-001AB
A075389-002AB
A075389-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-25caaa826d4ba7…
2026-08-18 06:07:402026-07A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075389-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2017-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075389-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2017-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075389-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2001-01-251e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075389-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075389-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075389-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075389-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075389-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075389-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075389-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075389-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075389-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075389-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075389-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075389-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075389-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075389-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075389-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075389-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075389-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075389-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075389-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075389-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075389-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075389-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075389-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075389-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075389-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075389-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075389-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075389-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075389-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075389-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075389-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075389-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075389-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075389-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075389-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075389-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075389-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075389-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075389-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075389-001AB11e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
555d5389-223f-1ce8-3064-82307acfdb0dProduct name420250325
b88d5283-0ee6-f0b3-21f1-5522444ef3dfProduct name320210204
555d5389-223f-1ce8-3064-82307acfdb0dProduct name320171213
1f5577c0-bdff-03f7-f803-d1d3f05329c2Product name120140508
a0ee8fe5-e56a-6ca2-24dc-111ec6d188e4Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-242-30EA - Each51862-242cc1e2404-d0e3-4b61-87f1-d5edc0d4e2ed12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-242AMIODARONE HYDROCHLORIDE TABLET [MAYNE PHARMA COMMERCIAL LLC]11Legacy NDC20241024_77ed916e-13bf-4249-bf45-5ae5d68a84fc.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEDr. Reddy's Labratories Inc.95cef33b-c0e6-b17c-7cbb-f5c0668727052026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075389
application number: ANDA075389
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAvPAK924c9359-ebc4-62a7-e053-2a95a90a43272026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075389
application number: ANDA075389

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-242-305186202423030 TABLET in 1 BOTTLE, PLASTIC (51862-242-30) 30 tablet2018-01-020000-00-00NoNoCurrent