Home NDC 63323-616 Amiodarone Hydrochloride
Product NDC 63323-616
11-digit product format 633230616
Labeler code 63323
Product ID 63323-616_262974e7-d551-4123-adfa-2ee1c4fa6195
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMIODARONE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA075761
Marketing category ANDA
Marketing start 2003-01-28
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 A075761-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075761-001 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 · 42 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 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075761-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2002-10-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1663224 Internal RxNorm lookup 1663244 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 63323-616-01 Amiodarone Hydrochloride 3 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 3 6 63323-616-02 Amiodarone Hydrochloride 9 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 9 6 63323-616-03 Amiodarone Hydrochloride 25 in 1 TRAY INJECTION, SOLUTION 25 6 63323-616-09 Amiodarone Hydrochloride 10 in 1 TRAY INJECTION, SOLUTION 10 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMIODARONE HYDROCHLORIDE ACTIVE INGREDIENT 976728SY6Z AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 AMIODARONE ACTIVE MOIETY N3RQ532IUT AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-616 AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 4 package rows 20250416_d8d04647-8e25-4127-8ecf-360ce1991c2f.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Fresenius Kabi USA, LLC d8d04647-8e25-4127-8ecf-360ce1991c2f 2025-03-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075761 application number: ANDA075761 ndc (product): 63323-616 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Fresenius Kabi USA, LLC 9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a 2025-03-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075761 application number: ANDA075761 Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE Medical Purchasing Solutions, LLC d889c00c-e27e-4e27-e053-2995a90ad4e1 2023-06-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075761 application number: ANDA075761 AMIODARONE HCI AMIODARONE HCI HF Acquisition Co LLC, DBA HealthFirst 993b2557-6774-bb7a-e053-2995a90a0503 2022-12-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075761 application number: ANDA075761
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 63323-616-01 63323061601 3 mL in 1 VIAL, SINGLE-DOSE 3 ml Historical 63323-616-02 63323061602 9 mL in 1 VIAL, SINGLE-DOSE 9 ml Historical 63323-616-03 63323061603 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-03) / 3 mL in 1 VIAL, SINGLE-DOSE (63323-616-01) 2003-01-28 0000-00-00 No No Current 63323-616-09 63323061609 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-09) / 9 mL in 1 VIAL, SINGLE-DOSE (63323-616-02) 2003-01-28 0000-00-00 No No Current