Amiodarone Hydrochloride
- Product NDC
- 0404-9815
- 11-digit product format
- 004049815
- Labeler code
- 0404
- Product ID
- 0404-9815_bd5fd1de-a30f-49d8-a0cb-9efdc4b8255b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc
- Application
- ANDA076217
- Marketing category
- ANDA
- Marketing start
- 2022-01-08
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9815 | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC] | 6 | Legacy NDC | 20241016_545e9d26-0b4a-4784-b9c4-f8d62caf3a7c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9815-03 | 00404981503 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9815-03) > 3 mL in 1 VIAL, SINGLE-DOSE | 2022-01-08 | 0000-00-00 | No | No | Current |