Home NDC 71872-7354 Amiodarone Hydrochloride
Product NDC 71872-7354
11-digit product format 718727354
Labeler code 71872
Product ID 71872-7354_4240b35d-54f7-737b-e063-6394a90a5588
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amiodarone hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Medical Purchasing Solutions, LLC.
Application ANDA218253
Marketing category ANDA
Marketing start 2024-10-31
Substance AMIODARONE HYDROCHLORIDE
Active strength 50 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218253-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218253-001 AP
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.
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 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218253-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-09-11 a50c72e98297…
Observed Orange Book normalized TE history# 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 50 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1663224 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 71872-7354-1 Amiodarone Hydrochloride 1 in 1 BAG INJECTION, SOLUTION 1 1 71872-7354-1 Amiodarone Hydrochloride 3 mL in 1 VIAL INJECTION, SOLUTION 3 1
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 Sample Exclude flag Status 71872-7354-1 71872735401 1 VIAL in 1 BAG (71872-7354-1) / 3 mL in 1 VIAL 1 vial 2025-07-07 No No Current