FDA.reportPublic FDA data

Amiodarone hydrochloride

Product NDC
65841-631
11-digit product format
658410631
Labeler code
65841
Product ID
65841-631_aabb5533-5d41-49a3-b8b6-14627af57311
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA079029
Marketing category
ANDA
Marketing start
2009-08-10
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
2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079029-001AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-16
A079029-002AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-06
A079029-003AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079029-001AB
A079029-002AB
A079029-003AB

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 3 · 92 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-06caaa826d4ba7…
2026-08-18 06:07:402026-07A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079029-002AMIODARONE HYDROCHLORIDE100MGTABLET / ORALAB2023-01-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079029-003AMIODARONE HYDROCHLORIDE400MGTABLET / ORALAB2023-01-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079029-001AMIODARONE HYDROCHLORIDE200MGTABLET / ORALAB2008-09-161e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A079029-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079029-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079029-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079029-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079029-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079029-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079029-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079029-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079029-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079029-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079029-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079029-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079029-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079029-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079029-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079029-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079029-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079029-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079029-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079029-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079029-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079029-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079029-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079029-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079029-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079029-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079029-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079029-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079029-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079029-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079029-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079029-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079029-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079029-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079029-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079029-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079029-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079029-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079029-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079029-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Amiodarone hydrochloride
Listing expiration
2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
833528Internal RxNorm lookup
834348Internal RxNorm lookup
835956Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e8db251-e3c5-4fba-be9a-6044a92f0bebAvailable 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
65841-631-05Amiodarone hydrochloride500 in 1 BOTTLETABLET50010
65841-631-06Amiodarone hydrochloride30 in 1 BOTTLETABLET3010
65841-631-10Amiodarone hydrochloride1000 in 1 BOTTLETABLET100010
65841-631-14Amiodarone hydrochloride60 in 1 BOTTLETABLET6010
65841-631-77Amiodarone hydrochloride10 in 1 BLISTER PACKTABLET1010
65841-631-77Amiodarone hydrochloride10 in 1 CARTONTABLET1010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMIODARONE HYDROCHLORIDEACTIVE INGREDIENT976728SY6ZAMIODARONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]2
AMIODARONEACTIVE MOIETYN3RQ532IUTAMIODARONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMIODARONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMIODARONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EAMIODARONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMIODARONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMIODARONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMIODARONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-631AMIODARONE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]10Current NDC, Legacy NDC, 6 package rows20241127_3e8db251-e3c5-4fba-be9a-6044a92f0beb.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amiodarone hydrochlorideAMIODARONE HYDROCHLORIDESafecor Health LLCf49d011f-5ca6-4f75-ba16-2099fe42f5aa2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079029
application number: ANDA079029
Amiodarone hydrochlorideAMIODARONE HYDROCHLORIDEZydus Lifesciences Limited3e8db251-e3c5-4fba-be9a-6044a92f0beb2024-11-25Exact identifier
application applno (ANDA): 079029
application number: ANDA079029
ndc (product): 65841-631
amiodarone hydrochlorideAMIODARONE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.b41cbcb5-9c5d-4e45-a4f2-952df5f22c002023-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079029
application number: ANDA079029

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835956amiodarone HCl 100 MG Oral TabletPSN3e8db251-e3c5-4fba-be9a-6044a92f0beb10
833528amiodarone HCl 200 MG Oral TabletPSN3e8db251-e3c5-4fba-be9a-6044a92f0beb10
834348amiodarone HCl 400 MG Oral TabletPSN3e8db251-e3c5-4fba-be9a-6044a92f0beb10
835956amiodarone hydrochloride 100 MG Oral TabletSCD3e8db251-e3c5-4fba-be9a-6044a92f0beb10
833528amiodarone hydrochloride 200 MG Oral TabletSCD3e8db251-e3c5-4fba-be9a-6044a92f0beb10
834348amiodarone hydrochloride 400 MG Oral TabletSCD3e8db251-e3c5-4fba-be9a-6044a92f0beb10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-631-0565841063105500 TABLET in 1 BOTTLE (65841-631-05) 500 tablet2009-08-100000-00-00NoNoCurrent
65841-631-066584106310630 TABLET in 1 BOTTLE (65841-631-06) 30 tablet2009-08-100000-00-00NoNoCurrent
65841-631-10658410631101000 TABLET in 1 BOTTLE (65841-631-10) 1000 tablet2009-08-100000-00-00NoNoCurrent
65841-631-146584106311460 TABLET in 1 BOTTLE (65841-631-14) 60 tablet2009-08-100000-00-00NoNoCurrent
65841-631-306584106313010 BLISTER PACK in 1 CARTON (65841-631-30) > 10 TABLET in 1 BLISTER PACK10 blister pack2009-08-100000-00-00NoNoCurrent
65841-631-776584106317710 BLISTER PACK in 1 CARTON (65841-631-77) / 10 TABLET in 1 BLISTER PACK10 blister pack2009-08-10NoNoCurrent