Home NDC 51672-4057 Amiodarone Hydrochloride
Product NDC 51672-4057
11-digit product format 516724057
Labeler code 51672
Product ID 51672-4057_4cc4c3cb-aced-a125-e063-6394a90aee93
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA076362
Marketing category ANDA
Marketing start 2002-11-29
Substance AMIODARONE HYDROCHLORIDE
Active strength 400 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076362-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL 2002-11-29 A076362-002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02
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 · 84 observed states.
Captured, Edition, Application-product table 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 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL 2002-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL 2002-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL 2002-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076362-001 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2002-11-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076362-002 AMIODARONE HYDROCHLORIDE 300MG TABLET / ORAL 2003-12-02 bb7c543d1eb4…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Amiodarone Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMIODARONE HYDROCHLORIDE 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 976728SY6Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 833528 Internal RxNorm lookup 834348 Internal RxNorm lookup 835956 Internal RxNorm lookup 835960 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-4057-0 Amiodarone Hydrochloride 10 in 1 CARTON TABLET 10 19 51672-4057-0 Amiodarone Hydrochloride 10 in 1 BLISTER PACK TABLET 10 19 51672-4057-6 Amiodarone Hydrochloride 30 in 1 BOTTLE TABLET 30 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Amiodarone Hydrochloride ACTIVE INGREDIENT 976728SY6Z AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 9 Amiodarone ACTIVE MOIETY N3RQ532IUT AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 9 aluminum oxide INACTIVE INGREDIENT LMI26O6933 AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 9 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 9 D&C yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 9 FD&C yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 9 magnesium stearate INACTIVE INGREDIENT 70097M6I30 AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 9 povidones INACTIVE INGREDIENT FZ989GH94E AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 9 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 9 starch, corn INACTIVE INGREDIENT O8232NY3SJ AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4057 AMIODARONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 18 Current NDC, Legacy NDC, 3 package rows 20250406_7ccd3733-c3af-4a11-8500-0f99194c1472.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4057-0 51672405700 10 BLISTER PACK in 1 CARTON (51672-4057-0) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2002-11-29 0000-00-00 No No Current 51672-4057-6 51672405706 30 TABLET in 1 BOTTLE (51672-4057-6) 30 tablet 2002-11-29 0000-00-00 No No Current