Home NDC 75907-006 Amiodarone Hydrochloride
Product NDC 75907-006
11-digit product format 759070006
Labeler code 75907
Product ID 75907-006_e0bc8f4a-dc9b-7804-4479-ebe732449569
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Labratories Inc.
Application ANDA075389
Marketing category ANDA
Marketing start 2024-03-15
Marketing end 2027-06-30
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
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 A075389-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 A075389-002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 A075389-003 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28
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 4 · 126 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 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075389-002 AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-12-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075389-003 AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2017-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075389-001 AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 2001-01-25 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Amiodarone Hydrochloride 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 75907-006-60 Amiodarone Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75907-006 AMIODARONE HYDROCHLORIDE TABLET [DR. REDDY'S LABRATORIES INC.] 1 Current NDC, 1 package rows 20240316_95cef33b-c0e6-b17c-7cbb-f5c066872705.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.
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 75907-006-60 75907000660 60 TABLET in 1 BOTTLE, PLASTIC (75907-006-60) 60 tablet 2024-03-15 2027-06-30 No No Historical