Amiodarone Injection
- Brand(s)
- Nexterone
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Baxter Healthcare Corporation (2015-03-13)
- Oldest Current Product
- 2002-10-14
- License(s)
- NDA, ANDA
- RxNORM
- INJECTION\AMIODARONE
- FDAOB
- INJECTION\INJECTION\AMIODARONE HYDROCHLORIDE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\AMIODARONE HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\AMIODARONE HYDROCHLORIDE
INTRAVENOUS\INJECTION\AMIODARONE HYDROCHLORIDE - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\AMIODARONE
INTRAVENOUS\INJECTION, SOLUTION\AMIODARONE
INTRAVENOUS\INJECTION\AMIODARONE
product(s) by strength(s)
100 ml amiodarone hydrochloride 1.5 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 430660150 | Nexterone | NDA | Baxter Healthcare Corporation | 2010-11-16 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | NDA022325 | e9108958-b8d7-4fba-87c3-9a32990de551 |
200 ml amiodarone hydrochloride 1.8 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 430660360 | Nexterone | NDA | Baxter Healthcare Corporation | 2010-11-16 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | NDA022325 | e9108958-b8d7-4fba-87c3-9a32990de551 |
amiodarone hydrochloride 50 mg/ml injection
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 633230616 | ANDA | App Pharmaceuticals, Llc | 2003-01-28 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA075761 | d8d04647-8e25-4127-8ecf-360ce1991c2f |
| 2 | 674570153 | ANDA | Mylan Institutional Llc | 2002-10-14 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA076217 | fcc8658c-761a-443f-8c32-1499d86028ec |
3 ml amiodarone hydrochloride 50 mg/ml injection
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001439875 | ANDA | West-Ward Pharmaceutical Corp | 2008-02-25 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA077234 | 51772745-9ea9-42cd-97e6-7266f41ae3ca |
| 2 | 004091934 | ANDA | Hospira, Inc. | 2013-11-25 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA203884 | 04efa7dc-7be0-495c-85a4-3d9d6ed5840a |
| 3 | 004094348 | ANDA | Hospira, Inc. | 2002-10-18 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA075955 | cdd50dc7-f712-4248-b0e3-ba247cf08cee |
| 4 | 556480739 | ANDA | Wockhardt Limited | 2008-10-30 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA077610 | b0eb6c22-7553-4e3f-a06d-20a186ced99a |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 525840153 | ANDA | General Injecatables & Vaccines, Inc | 2012-06-06 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | 674570153 | ANDA076217 | b7e2af06-1fe4-4b45-ae5d-bc6279ca47f3 |
| 2 | 525840348 | ANDA | General Injecatables & Vaccines, Inc | 2010-03-01 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | 004094348 | ANDA075955 | f446e1b0-2c46-4763-8eb0-b3a6be956f69 |
| 3 | 525840875 | ANDA | General Injecatables & Vaccines, Inc | 2014-09-02 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION | 001439875 | ANDA077234 | c5d11e6d-d78f-40f0-87bd-6909088141d0 |
| 4 | 548685722 | ANDA | Physicians Total Care, Inc. | 2006-12-11 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | 674570153 | ANDA076217 | 304d0be4-0c13-4dbb-8ffb-b2e7caa7fb1e |
| 5 | 617860394 | ANDA | Remedyrepack Inc. | 2015-08-19 | AMIODARONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | 001439875 | ANDA077234 | 2ae89f66-73cc-414d-a173-b23d9607ccb9 |
application(s)
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA075761_001 | RX | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | True | AP | 2002-10-15 | AMIODARONE HYDROCHLORIDE |
| 2 | ANDA075955_001 | RX | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | True | AP | 2002-10-18 | AMIODARONE HYDROCHLORIDE |
| 3 | ANDA076018_001 | discontinued | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | 2002-10-15 | AMIODARONE HYDROCHLORIDE | |
| 4 | ANDA076088_001 | discontinued | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | 2002-10-15 | AMIODARONE HYDROCHLORIDE | |
| 5 | ANDA076108_001 | discontinued | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | 2002-10-15 | AMIODARONE HYDROCHLORIDE | |
| 6 | ANDA076163_001 | discontinued | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | 2003-09-05 | AMIODARONE HYDROCHLORIDE | |
| 7 | ANDA076217_001 | RX | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | True | AP | 2002-10-15 | AMIODARONE HYDROCHLORIDE |
| 8 | ANDA076232_001 | RX | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | True | AP | 2006-07-05 | AMIODARONE HYDROCHLORIDE |
| 9 | ANDA076299_001 | discontinued | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | 2002-10-24 | AMIODARONE HYDROCHLORIDE | |
| 10 | ANDA076394_001 | discontinued | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | 2003-04-25 | AMIODARONE HYDROCHLORIDE | |
| 11 | ANDA077161_001 | RX | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | True | AP | 2005-04-20 | AMIODARONE HYDROCHLORIDE |
| 12 | ANDA077234_001 | RX | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | AP | 2008-02-25 | AMIODARONE HYDROCHLORIDE |
| 13 | ANDA077610_001 | RX | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | AP | 2008-10-30 | AMIODARONE HYDROCHLORIDE |
| 14 | ANDA077834_001 | RX | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | AP | 2008-10-30 | AMIODARONE HYDROCHLORIDE |
| 15 | ANDA203884_001 | RX | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | AP | 2013-11-25 | AMIODARONE HYDROCHLORIDE |
| 16 | ANDA203885_001 | RX | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | AP | 2013-11-25 | AMIODARONE HYDROCHLORIDE |
| 17 | NDA020377_001 | discontinued | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | 1995-08-03 | CORDARONE | |
| 18 | NDA021594_001 | discontinued | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | 2004-02-04 | AMIODARONE HYDROCHLORIDE | |
| 19 | NDA022325_001 | RX | AMIODARONE HYDROCHLORIDE (50MG/ML) | INJECTION | False | AP | 2008-12-24 | NEXTERONE |
| 20 | NDA022325_002 | RX | AMIODARONE HYDROCHLORIDE (150MG/100ML) | INJECTION | True | 2010-11-16 | NEXTERONE | |
| 21 | NDA022325_003 | RX | AMIODARONE HYDROCHLORIDE (360MG/200ML) | INJECTION | True | 2010-11-16 | NEXTERONE |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p6869939 (view patent) | 2022-05-04 | NDA022325 | Amiodarone Prefilled Syringe Amiodarone Injectable Solution |
| 2 | p7635773 (view patent) | 2029-03-13 | NDA022325 | Amiodarone Prefilled Syringe Amiodarone Injectable Solution |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 04efa7dc-7be0-495c-85a4-3d9d6ed5840a (view SPL) | These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1985 | prescription | Human Prescription | Hospira, Inc. | 2013-12-02 | 1 | 004091934, 004091933 | Amiodarone Injectable Solution | |
| 2 | 2ae89f66-73cc-414d-a173-b23d9607ccb9 (view SPL) | These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1985 | prescription | Human Prescription | Remedyrepack Inc. | 2015-08-19 | 1 | 617860394 | ||
| 3 | 304d0be4-0c13-4dbb-8ffb-b2e7caa7fb1e (view SPL) | These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1985 | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2012-03-08 | 1 | 548685722 | |
| 4 | 51772745-9ea9-42cd-97e6-7266f41ae3ca (view SPL) | These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1985 | prescription | Human Prescription | West-Ward Pharmaceutical Corp | MANUFACTURE | 2012-12-04 | 4 | 001439875 | |
| 5 | b0eb6c22-7553-4e3f-a06d-20a186ced99a (view SPL) | These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl Injection for intravenous useInitial U.S. Approval: 1985 | prescription | Human Prescription | Wockhardt Limited | ANALYSIS, LABEL, MANUFACTURE, PACK | 2012-11-06 | 1 | 556480739 | |
| 6 | b7e2af06-1fe4-4b45-ae5d-bc6279ca47f3 (view SPL) | These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCL injection for intravenous use Initial U.S. Approval: 1985 | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2012-12-19 | 2 | 525840153 | ||
| 7 | c5d11e6d-d78f-40f0-87bd-6909088141d0 (view SPL) | AMIODARONE HYDROCHLORIDE HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use amiodarone safely and effectively.See full prescribing information for amiodarone injection.Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1995 | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2014-09-02 | 1 | 525840875 | ||
| 8 | cdd50dc7-f712-4248-b0e3-ba247cf08cee (view SPL) | These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection.Amiodarone HCl injection for intravenous useInitial U.S. Approval: 1995 | prescription | Human Prescription | Hospira, Inc. | 2013-03-01 | 11 | 004094348 | ||
| 9 | d8d04647-8e25-4127-8ecf-360ce1991c2f (view SPL) | Amiodarone Hydrochloride Injection | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2012-01-25 | 1 | 633230616 | |
| 10 | e9108958-b8d7-4fba-87c3-9a32990de551 (view SPL) | These highlights do not include all the information needed to use NEXTERONE safely and effectively. See full prescribing information for NEXTERONE. NEXTERONE (amiodarone HCl) Premixed Injection for intravenous useInitial U.S. Approval: 1985 | prescription | Human Prescription | Baxter Healthcare Corporation | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2015-03-13 | 6 | 430660150, 430660360 | |
| 11 | f446e1b0-2c46-4763-8eb0-b3a6be956f69 (view SPL) | These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection.Amiodarone HCL injection for intravenous useInitial U.S. Approval: 1995 | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2013-09-06 | 4 | 525840348 | ||
| 12 | fcc8658c-761a-443f-8c32-1499d86028ec (view SPL) | These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1985 | prescription | Human Prescription | Mylan Institutional Llc | 2012-08-31 | 8 | 674570153 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII