Amiodarone Hydrochloride
- Product NDC
- 71335-0881
- 11-digit product format
- 713350881
- Labeler code
- 71335
- Product ID
- 71335-0881_a148ddb8-adb0-46dc-90ed-7df37af2a4ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075424
- Marketing category
- ANDA
- Marketing start
- 2001-03-30
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 200 mg/1
- 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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMIODARONE HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 976728SY6Z |
| Rxcui | 833528 |
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 |
| a0ee8fe5-e56a-6ca2-24dc-111ec6d188e4 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-0881-1 | Amiodarone Hydrochloride | 200 in 1 BOTTLE | TABLET | 200 | 5 | |
| 71335-0881-2 | Amiodarone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 5 | |
| 71335-0881-3 | Amiodarone Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 5 | |
| 71335-0881-4 | Amiodarone Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 5 | |
| 71335-0881-5 | Amiodarone Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-0881-2 | EA - Each | 71335-0881 | fe54aca0-8173-45b3-b41c-17f9bea7ec43 | 1 | 2020-09-14 |
| 71335-0881-4 | EA - Each | 71335-0881 | ca2f5867-db83-44db-a3f4-f5e43cc4b469 | 1 | 2020-09-14 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-0881 | AMIODARONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 5 package rows | 20240522_f3e631c5-1204-419c-8dbe-fa9b37a77f97.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 833528 | amiodarone HCl 200 MG Oral Tablet | PSN | f3e631c5-1204-419c-8dbe-fa9b37a77f97 | 5 |
| 833528 | amiodarone hydrochloride 200 MG Oral Tablet | SCD | f3e631c5-1204-419c-8dbe-fa9b37a77f97 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-0881-1 | 71335088101 | 200 TABLET in 1 BOTTLE (71335-0881-1) | 200 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0881-2 | 71335088102 | 30 TABLET in 1 BOTTLE (71335-0881-2) | 30 tablet | 2019-01-03 | 0000-00-00 | No | No | Current |
| 71335-0881-3 | 71335088103 | 60 TABLET in 1 BOTTLE (71335-0881-3) | 60 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0881-4 | 71335088104 | 90 TABLET in 1 BOTTLE (71335-0881-4) | 90 tablet | 2018-06-26 | 0000-00-00 | No | No | Current |
| 71335-0881-5 | 71335088105 | 10 TABLET in 1 BOTTLE (71335-0881-5) | 10 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |