Amiodarone hydrochloride
- Product NDC
- 21695-796
- 11-digit product format
- 216950796
- Labeler code
- 21695
- Product ID
- 21695-796_e1a80191-fcb5-4aab-a972-accabe6ae9c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA079029
- Marketing category
- ANDA
- Marketing start
- 2009-08-10
- Marketing end
- 0000-00-00
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-796-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4c23-48b1-e053-8cdaa90a720a | Amiodarone Hydrochloride Tablets |
| 21695-796-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4c23-48b1-e053-8cdaa90a720a | Amiodarone Hydrochloride Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-796-30 | Amiodarone hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-796-90 | Amiodarone hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-796-30 | EA - Each | 21695-796 | 53bb828f-07a4-419a-8c06-fe1f74c77b9e | 1 | 2012-07-24 |
| 21695-796-90 | EA - Each | 21695-796 | e8c9c214-1376-4655-a366-309f44d1e0ab | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | ACTIVE INGREDIENT | 976728SY6Z | AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| AMIODARONE | ACTIVE MOIETY | N3RQ532IUT | AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 833528 | amiodarone HCl 200 MG Oral Tablet | PSN | e1a80191-fcb5-4aab-a972-accabe6ae9c7 | 1 |
| 833528 | amiodarone hydrochloride 200 MG Oral Tablet | SCD | e1a80191-fcb5-4aab-a972-accabe6ae9c7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-796-30 | 21695079630 | 30 in 1 BOTTLE | Historical |
| 21695-796-90 | 21695079690 | 90 in 1 BOTTLE | Historical |