Home NDC 68382-227 amiodarone hydrochloride
Product NDC 68382-227
11-digit product format 683820227
Labeler code 68382
Product ID 68382-227_b3f11ad6-9f3b-4054-9c51-3d2614c1002e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amiodarone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
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 3A4 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-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# Current TE-code rows page 1 of 1 · 3 matching rows.
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 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# Normalized TE history page 1 of 3 · 92 observed states.
Additional Listing Data#
Finished product Yes
Brand name base amiodarone hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMIODARONE HYDROCHLORIDE 200 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 833528 Internal RxNorm lookup 834348 Internal RxNorm lookup 835956 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 68382-227-05 amiodarone hydrochloride 500 in 1 BOTTLE TABLET 500 19 68382-227-06 amiodarone hydrochloride 30 in 1 BOTTLE TABLET 30 19 68382-227-10 amiodarone hydrochloride 1000 in 1 BOTTLE TABLET 1000 19 68382-227-14 amiodarone hydrochloride 60 in 1 BOTTLE TABLET 60 19 68382-227-30 amiodarone hydrochloride 1 in 1 BLISTER PACK TABLET 1 19 68382-227-77 amiodarone hydrochloride 100 in 1 CARTON TABLET 100 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMIODARONE HYDROCHLORIDE ACTIVE INGREDIENT 976728SY6Z AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 AMIODARONE ACTIVE MOIETY N3RQ532IUT AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 POVIDONE INACTIVE INGREDIENT FZ989GH94E AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 7 AMIODARONE HYDROCHLORIDE ACTIVE INGREDIENT 976728SY6Z AMIODARONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 5 AMIODARONE ACTIVE MOIETY N3RQ532IUT AMIODARONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AMIODARONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMIODARONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 5 POVIDONES INACTIVE INGREDIENT FZ989GH94E AMIODARONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMIODARONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMIODARONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMIODARONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 5 AMIODARONE HYDROCHLORIDE ACTIVE INGREDIENT 976728SY6Z AMIODARONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 AMIODARONE HYDROCHLORIDE ACTIVE INGREDIENT 976728SY6Z AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 AMIODARONE HYDROCHLORIDE ACTIVE INGREDIENT 976728SY6Z AMIODARONE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 AMIODARONE ACTIVE MOIETY N3RQ532IUT AMIODARONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 AMIODARONE ACTIVE MOIETY N3RQ532IUT AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 AMIODARONE ACTIVE MOIETY N3RQ532IUT AMIODARONE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMIODARONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMIODARONE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AMIODARONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AMIODARONE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMIODARONE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMIODARONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E AMIODARONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E AMIODARONE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMIODARONE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMIODARONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMIODARONE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMIODARONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-227 AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS USA INC.] 19 Current NDC, Legacy NDC, 6 package rows 20230317_b41cbcb5-9c5d-4e45-a4f2-952df5f22c00.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.
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 68382-227-05 68382022705 500 TABLET in 1 BOTTLE (68382-227-05) 500 tablet 2009-08-10 0000-00-00 No No Current 68382-227-06 68382022706 30 TABLET in 1 BOTTLE (68382-227-06) 30 tablet 2009-08-10 0000-00-00 No No Current 68382-227-10 68382022710 1000 TABLET in 1 BOTTLE (68382-227-10) 1000 tablet 2009-08-10 0000-00-00 No No Current 68382-227-14 68382022714 60 TABLET in 1 BOTTLE (68382-227-14) 60 tablet 2009-08-10 0000-00-00 No No Current 68382-227-30 68382022730 1 in 1 BLISTER PACK Historical 68382-227-77 68382022777 100 BLISTER PACK in 1 CARTON (68382-227-77) / 1 TABLET in 1 BLISTER PACK (68382-227-30) 100 blister pack 2009-08-10 0000-00-00 No No Current