Amiodarone Hydrochloride

Product NDC: 67457-153
11-digit product format: 674570153
Labeler code: 67457
Product ID: 67457-153_bd9c578c-322f-41fc-936d-bf9b551a2782
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amiodarone hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Mylan Institutional LLC
Application: ANDA076217
Marketing category: ANDA
Marketing start: 2002-10-14
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
A076217-001	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
A076217-001	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	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076217-001	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	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076217-001	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	A076217-001	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	A076217-001	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	A076217-001	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	A076217-001	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	A076217-001	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	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076217-001	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	A076217-001	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	A076217-001	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	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076217-001	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	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076217-001	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	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076217-001	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	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076217-001	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	A076217-001	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	A076217-001	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	A076217-001	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	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076217-001	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	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076217-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076217-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076217-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076217-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076217-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076217-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076217-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076217-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076217-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076217-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076217-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076217-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076217-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076217-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076217-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076217-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076217-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076217-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076217-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076217-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076217-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076217-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076217-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076217-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076217-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076217-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076217-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076217-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076217-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076217-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076217-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076217-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076217-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076217-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076217-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076217-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076217-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076217-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076217-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076217-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076217-001	AP	1	`e64feba35796…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1663224	Internal RxNorm lookup
1663244	Internal RxNorm lookup
1663248	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fcc8658c-761a-443f-8c32-1499d86028ec	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
555d5389-223f-1ce8-3064-82307acfdb0d	Product name	4	20250325
b88d5283-0ee6-f0b3-21f1-5522444ef3df	Product name	3	20210204
555d5389-223f-1ce8-3064-82307acfdb0d	Product name	3	20171213
1f5577c0-bdff-03f7-f803-d1d3f05329c2	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
a0ee8fe5-e56a-6ca2-24dc-111ec6d188e4	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67457-153-00	Amiodarone Hydrochloride	3 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	3	17
67457-153-03	Amiodarone Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10	17
67457-153-09	Amiodarone Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10	17
67457-153-18	Amiodarone Hydrochloride	18 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	18	17
67457-153-18	Amiodarone Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1	17
67457-153-99	Amiodarone Hydrochloride	9 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	9	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-153-00	ML - Milliliter	67457-153	7168fefb-1564-462c-969e-0394f2682398	1	2015-08-04
67457-153-03	ML - Milliliter	67457-153	cded1d68-e294-4516-a049-93e827342fb0	1	2012-07-24
67457-153-09	ML - Milliliter	67457-153	6476ab0b-7de7-41bc-af11-09227c7e5a5e	1	2012-07-24
67457-153-18	ML - Milliliter	67457-153	5eaef046-284e-4c97-8f2a-43a438166b41	1	2012-07-24
67457-153-99	ML - Milliliter	67457-153	6d642ff4-c140-4aa8-8b54-24c8a08a1869	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Amiodarone Hydrochloride	ACTIVE INGREDIENT	976728SY6Z	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	8
Amiodarone	ACTIVE MOIETY	N3RQ532IUT	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	8
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	8
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	8
water	INACTIVE INGREDIENT	059QF0KO0R	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	8
Amiodarone Hydrochloride	ACTIVE INGREDIENT	976728SY6Z	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
Amiodarone	ACTIVE MOIETY	N3RQ532IUT	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
Amiodarone Hydrochloride	ACTIVE INGREDIENT	976728SY6Z	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
Amiodarone	ACTIVE MOIETY	N3RQ532IUT	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-153	AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	17	Current NDC, Legacy NDC, 6 package rows	20201120_fcc8658c-761a-443f-8c32-1499d86028ec.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	ProPharma Distribution	364ab45e-b525-f310-e063-6394a90a4421	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076217 application number: ANDA076217
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	8d088060-70b5-e796-e053-2995a90a0969	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076217 application number: ANDA076217
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	8969aad3-0219-e67f-e053-2995a90aac5a	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076217 application number: ANDA076217
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Mylan Institutional LLC	f0b3b743-9f62-4b02-ace5-c8d93637ecad	2022-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076217 application number: ANDA076217
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Mylan Institutional LLC	fcc8658c-761a-443f-8c32-1499d86028ec	2020-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076217 application number: ANDA076217 ndc (product): 67457-153

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
976728SY6Z	AMIODARONE HYDROCHLORIDE	19774-82-4	AMIODARONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1663224	amiodarone HCl 150 MG in 3 ML Injection	PSN	fcc8658c-761a-443f-8c32-1499d86028ec	17
1663244	amiodarone HCl 450 MG in 9 ML Injection	PSN	fcc8658c-761a-443f-8c32-1499d86028ec	17
1663248	amiodarone HCl 900 MG in 18 ML Injection	PSN	fcc8658c-761a-443f-8c32-1499d86028ec	17
1663248	18 ML amiodarone hydrochloride 50 MG/ML Injection	SCD	fcc8658c-761a-443f-8c32-1499d86028ec	17
1663224	3 ML amiodarone hydrochloride 50 MG/ML Injection	SCD	fcc8658c-761a-443f-8c32-1499d86028ec	17
1663244	9 ML amiodarone hydrochloride 50 MG/ML Injection	SCD	fcc8658c-761a-443f-8c32-1499d86028ec	17
1663224	amiodarone HCl 150 MG per 3 ML Injection	SY	fcc8658c-761a-443f-8c32-1499d86028ec	17
1663244	amiodarone HCl 450 MG per 9 ML Injection	SY	fcc8658c-761a-443f-8c32-1499d86028ec	17
1663248	amiodarone HCl 900 MG per 18 ML Injection	SY	fcc8658c-761a-443f-8c32-1499d86028ec	17
1663224	amiodarone HCl 150 MG in 3 ML Injection	PSN	364ab45e-b525-f310-e063-6394a90a4421	3
1663224	3 ML amiodarone hydrochloride 50 MG/ML Injection	SCD	364ab45e-b525-f310-e063-6394a90a4421	3
1663224	amiodarone HCl 150 MG per 3 ML Injection	SY	364ab45e-b525-f310-e063-6394a90a4421	3
1663224	amiodarone HCl 150 MG in 3 ML Injection	PSN	8969aad3-0219-e67f-e053-2995a90aac5a	2
1663224	3 ML amiodarone hydrochloride 50 MG/ML Injection	SCD	8969aad3-0219-e67f-e053-2995a90aac5a	2
1663224	amiodarone HCl 150 MG per 3 ML Injection	SY	8969aad3-0219-e67f-e053-2995a90aac5a	2
1663224	amiodarone HCl 150 MG in 3 ML Injection	PSN	304d0be4-0c13-4dbb-8ffb-b2e7caa7fb1e	1
1663224	3 ML amiodarone hydrochloride 50 MG/ML Injection	SCD	304d0be4-0c13-4dbb-8ffb-b2e7caa7fb1e	1
1663224	amiodarone HCl 150 MG per 3 ML Injection	SY	304d0be4-0c13-4dbb-8ffb-b2e7caa7fb1e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-153-00	67457015300	3 mL in 1 VIAL, GLASS	3 ml					Historical
67457-153-03	67457015303	10 VIAL, GLASS in 1 CARTON (67457-153-03) / 3 mL in 1 VIAL, GLASS (67457-153-00)		2002-10-15	0000-00-00	No	No	Current
67457-153-09	67457015309	10 VIAL, GLASS in 1 CARTON (67457-153-09) / 9 mL in 1 VIAL, GLASS (67457-153-99)		2004-01-05	0000-00-00	No	No	Current
67457-153-18	67457015318	1 VIAL, GLASS in 1 CARTON (67457-153-18) / 18 mL in 1 VIAL, GLASS		2003-11-14	0000-00-00	No	No	Current
67457-153-99	67457015399	9 mL in 1 VIAL, GLASS	9 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amiodarone Hydrochloride	ProPharma Distribution	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	3
Amiodarone Hydrochloride	Henry Schein, Inc	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	7
AMIODARONE HYDROCHLORIDE INJECTION 900mg/18mL (50mg/mL) 18mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-28	HUMAN PRESCRIPTION DRUG LABEL	4
Amiodarone Hydrochloride	Medical Purchasing Solutions, LLC	2023-05-15	HUMAN PRESCRIPTION DRUG LABEL	2
Amiodarone Hydrochloride	General Injectables & Vaccines, Inc	2022-12-07	HUMAN PRESCRIPTION DRUG LABEL	8
Amiodarone Hydrochloride	Mylan Institutional LLC	2020-07-15	HUMAN PRESCRIPTION DRUG LABEL	17
Amiodarone Hydrochloride	Physicians Total Care, Inc.	2012-03-08	HUMAN PRESCRIPTION DRUG LABEL	1