Amiodarone Hydrochloride
- Product NDC
- 72673-071
- 11-digit product format
- 726730071
- Labeler code
- 72673
- Product ID
- 72673-071_487d000e-9dec-3e6f-e063-6294a90ae8b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amiodarone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Zhejiang Poly Pharm. Co., Ltd.
- Application
- ANDA218253
- Marketing category
- ANDA
- Marketing start
- 2023-02-06
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amiodarone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMIODARONE HYDROCHLORIDE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 976728SY6Z |
| Rxcui | 1663224, 1663244, 1663248 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72673-071-10 | Amiodarone Hydrochloride | 3 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 3 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72673-071 | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [ZHEJIANG POLY PHARM. CO., LTD.] | 5 | Current NDC, 1 package rows | 20240930_0a28ae25-7cc4-4ac0-a2ba-7820fb93e25c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72673-071-10 | 72673007110 | 3 mL in 1 VIAL, GLASS (72673-071-10) | 3 ml | 2023-02-06 | No | No | Historical |