Home NDC 71872-7000 Amiodarone Hydrochloride
Product NDC 71872-7000
11-digit product format 718727000
Labeler code 71872
Product ID 71872-7000_fe91f01c-a089-a2b2-e053-6394a90a79a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Medical Purchasing Solutions, LLC
Application ANDA077234
Marketing category ANDA
Marketing start 2008-02-25
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 44 .
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 A077234-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077234-001 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.
Product history page 1 of 2 · 44 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 2026-10-15 13:18:30 2026-09 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077234-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-02-25 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 71872-7000-1 Amiodarone Hydrochloride 3 mL in 1 VIAL INJECTION, SOLUTION 3 5 71872-7000-1 Amiodarone Hydrochloride 1 in 1 BAG INJECTION, SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71872-7000 AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20230621_66700f8b-3f76-3749-e053-2a91aa0adfdb.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 · 4 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 71872-7000-1 71872700001 1 VIAL in 1 BAG (71872-7000-1) / 3 mL in 1 VIAL 1 vial 2018-02-28 0000-00-00 No No Current