Home NDC 68083-112 Amiodarone hydrochloride
Product NDC 68083-112
11-digit product format 680830112
Labeler code 68083
Product ID 68083-112_2c1bc6a8-20ff-483a-ae28-fb31fa5f684a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA077161
Marketing category ANDA
Marketing start 2013-07-15
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077161-001 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077161-001 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 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077161-001 AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP RS 2005-04-20 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 834357 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 68083-112-01 Amiodarone hydrochloride 3 mL in 1 SYRINGE INJECTION, SOLUTION 3 5 68083-112-01 Amiodarone hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-112 AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20210827_1f00c333-9667-4ebc-8849-009a3779c0c9.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 · 1 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 68083-112-01 68083011201 10 SYRINGE in 1 CARTON (68083-112-01) / 3 mL in 1 SYRINGE 10 syringe 2013-07-15 0000-00-00 No No Current