Amiodarone Hydrochloride
- Product NDC
- 0143-9875
- 11-digit product format
- 001439875
- Labeler code
- 0143
- Product ID
- 0143-9875_624376cc-5fa3-410a-95de-ef975e2ea501
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amiodarone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMIODARONE HYDROCHLORIDE | 50 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 976728SY6Z |
| Rxcui | 1663224 |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9875-01 | Amiodarone Hydrochloride | 3 mL in 1 VIAL | INJECTION, SOLUTION | 3 | 9 | |
| 0143-9875-10 | Amiodarone Hydrochloride | 10 in 1 BOX | INJECTION, SOLUTION | 10 | 9 | |
| 0143-9875-25 | Amiodarone Hydrochloride | 25 in 1 BOX | INJECTION, SOLUTION | 25 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9875-01 | ML - Milliliter | 0143-9875 | 35f8ce31-59a3-4017-876c-25a6ecd9ef59 | 1 | 2015-11-12 |
| 0143-9875-10 | ML - Milliliter | 0143-9875 | 260fc820-5fdb-4bec-b572-1b02d1546bc3 | 1 | 2012-07-24 |
| 0143-9875-25 | ML - Milliliter | 0143-9875 | bfa24696-988c-4103-b789-da260d977689 | 1 | 2017-04-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | ACTIVE INGREDIENT | 976728SY6Z | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| AMIODARONE | ACTIVE MOIETY | N3RQ532IUT | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1663224 | amiodarone HCl 150 MG in 3 ML Injection | PSN | e9151c1b-b70c-477b-868a-fffdc5c51830 | 11 |
| 1663224 | 3 ML amiodarone hydrochloride 50 MG/ML Injection | SCD | e9151c1b-b70c-477b-868a-fffdc5c51830 | 11 |
| 1663224 | amiodarone HCl 150 MG per 3 ML Injection | SY | e9151c1b-b70c-477b-868a-fffdc5c51830 | 11 |
| 1663224 | amiodarone HCl 150 MG in 3 ML Injection | PSN | 51772745-9ea9-42cd-97e6-7266f41ae3ca | 9 |
| 1663224 | 3 ML amiodarone hydrochloride 50 MG/ML Injection | SCD | 51772745-9ea9-42cd-97e6-7266f41ae3ca | 9 |
| 1663224 | amiodarone HCl 150 MG per 3 ML Injection | SY | 51772745-9ea9-42cd-97e6-7266f41ae3ca | 9 |
| 1663224 | amiodarone HCl 150 MG in 3 ML Injection | PSN | 7639dfe4-933c-2916-e053-2a91aa0a3fe7 | 7 |
| 1663224 | 3 ML amiodarone hydrochloride 50 MG/ML Injection | SCD | 7639dfe4-933c-2916-e053-2a91aa0a3fe7 | 7 |
| 1663224 | amiodarone HCl 150 MG per 3 ML Injection | SY | 7639dfe4-933c-2916-e053-2a91aa0a3fe7 | 7 |
| 1663224 | amiodarone HCl 150 MG in 3 ML Injection | PSN | 66700f8b-3f76-3749-e053-2a91aa0adfdb | 5 |
| 1663224 | 3 ML amiodarone hydrochloride 50 MG/ML Injection | SCD | 66700f8b-3f76-3749-e053-2a91aa0adfdb | 5 |
| 1663224 | amiodarone HCl 150 MG per 3 ML Injection | SY | 66700f8b-3f76-3749-e053-2a91aa0adfdb | 5 |
| 1663224 | amiodarone HCl 150 MG in 3 ML Injection | PSN | 0c9ee15a-5741-4aaa-8d80-c7bd2e45822e | 1 |
| 1663224 | 3 ML amiodarone hydrochloride 50 MG/ML Injection | SCD | 0c9ee15a-5741-4aaa-8d80-c7bd2e45822e | 1 |
| 1663224 | amiodarone HCl 150 MG per 3 ML Injection | SY | 0c9ee15a-5741-4aaa-8d80-c7bd2e45822e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0143-9875-01 | 00143987501 | 3 mL in 1 VIAL | 3 ml | Historical | ||||
| 0143-9875-10 | 00143987510 | 10 VIAL in 1 BOX (0143-9875-10) / 3 mL in 1 VIAL (0143-9875-01) | 10 vial | 2008-02-25 | 0000-00-00 | No | No | Current |
| 0143-9875-25 | 00143987525 | 25 VIAL in 1 BOX (0143-9875-25) / 3 mL in 1 VIAL (0143-9875-01) | 25 vial | 2008-02-25 | 0000-00-00 | No | No | Current |