Amiodarone Hydrochloride

Product NDC
65862-732
11-digit product format
658620732
Labeler code
65862
Product ID
65862-732_84ad18a0-1887-4b62-8ac1-94ace3433366
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204742
Marketing category
ANDA
Marketing start
2016-06-03
Substance
AMIODARONE HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204742-001AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204742-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-033f01610625f2…
2019-09-15 20:21 UTC2019-09A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204742-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2016-06-03e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204742-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204742-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204742-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204742-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204742-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204742-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204742-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204742-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204742-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204742-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204742-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204742-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204742-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204742-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204742-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204742-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204742-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204742-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204742-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204742-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204742-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204742-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204742-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204742-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204742-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204742-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204742-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204742-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204742-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204742-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204742-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204742-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204742-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204742-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204742-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204742-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204742-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204742-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204742-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204742-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Amiodarone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
976728SY6ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
833528Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ae393d1-7469-432a-9f21-f5ebab1207d1Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-732-01Amiodarone Hydrochloride100 in 1 BOTTLETABLET10010
65862-732-05Amiodarone Hydrochloride500 in 1 BOTTLETABLET50010
65862-732-25Amiodarone Hydrochloride250 in 1 BOTTLETABLET25010
65862-732-30Amiodarone Hydrochloride30 in 1 BOTTLETABLET3010
65862-732-60Amiodarone Hydrochloride60 in 1 BOTTLETABLET6010
65862-732-90Amiodarone Hydrochloride90 in 1 BOTTLETABLET9010
65862-732-99Amiodarone Hydrochloride1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-732-05EA - Each65862-732efddf78d-9881-436b-97ec-c6733b7552f412016-07-19
65862-732-60EA - Each65862-73279a1dfdf-4d01-4775-bac1-23dd7dc3a55012016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-732AMIODARONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 7 package rows20240615_7ae393d1-7469-432a-9f21-f5ebab1207d1.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEREMEDYREPACK INC.51a88e8e-da02-4b97-9e7e-442fbffd908d2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204742
application number: ANDA204742
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDECardinal Health 107, LLC0caedb97-56fd-4ec0-bfb2-c7683b8f5f1b2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204742
application number: ANDA204742
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAurobindo Pharma Limited7ae393d1-7469-432a-9f21-f5ebab1207d12026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204742
application number: ANDA204742
ndc (product): 65862-732
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAmerican Health Packagingd912a75a-ddac-4e7b-b5c4-321d4252ec052025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204742
application number: ANDA204742
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsd42293e9-07fa-41b4-a08b-2e388f5b1e132024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204742
application number: ANDA204742
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEA-S Medication Solutionsbfd14110-4bf8-4fbe-a888-7b23fea6ffaa2024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204742
application number: ANDA204742

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSN51a88e8e-da02-4b97-9e7e-442fbffd908d11
833528amiodarone hydrochloride 200 MG Oral TabletSCD51a88e8e-da02-4b97-9e7e-442fbffd908d11
833528amiodarone HCl 200 MG Oral TabletPSN7ae393d1-7469-432a-9f21-f5ebab1207d110
833528amiodarone HCl 200 MG Oral TabletPSNbfd14110-4bf8-4fbe-a888-7b23fea6ffaa10
833528amiodarone hydrochloride 200 MG Oral TabletSCD7ae393d1-7469-432a-9f21-f5ebab1207d110
833528amiodarone hydrochloride 200 MG Oral TabletSCDbfd14110-4bf8-4fbe-a888-7b23fea6ffaa10
833528amiodarone HCl 200 MG Oral TabletPSNd912a75a-ddac-4e7b-b5c4-321d4252ec057
833528amiodarone hydrochloride 200 MG Oral TabletSCDd912a75a-ddac-4e7b-b5c4-321d4252ec057
833528amiodarone HCl 200 MG Oral TabletPSNd42293e9-07fa-41b4-a08b-2e388f5b1e134
833528amiodarone hydrochloride 200 MG Oral TabletSCDd42293e9-07fa-41b4-a08b-2e388f5b1e134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-732-0165862073201100 TABLET in 1 BOTTLE (65862-732-01) 100 tablet2016-06-030000-00-00NoNoCurrent
65862-732-0565862073205500 TABLET in 1 BOTTLE (65862-732-05) 500 tablet2016-06-030000-00-00NoNoCurrent
65862-732-2565862073225250 TABLET in 1 BOTTLE (65862-732-25) 250 tablet2016-06-030000-00-00NoNoCurrent
65862-732-306586207323030 TABLET in 1 BOTTLE (65862-732-30) 30 tablet2016-06-030000-00-00NoNoCurrent
65862-732-606586207326060 TABLET in 1 BOTTLE (65862-732-60) 60 tablet2016-06-030000-00-00NoNoCurrent
65862-732-906586207329090 TABLET in 1 BOTTLE (65862-732-90) 90 tablet2016-06-030000-00-00NoNoCurrent
65862-732-99658620732991000 TABLET in 1 BOTTLE (65862-732-99) 1000 tablet2016-06-030000-00-00NoNoCurrent