Pacerone
- Product NDC
- 72162-2148
- 11-digit product format
- 721622148
- Labeler code
- 72162
- Product ID
- 72162-2148_b3dbe38d-29a3-41a9-a51c-0cc3bf8eb9e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075135
- Marketing category
- ANDA
- Marketing start
- 2010-11-15
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 100 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 976728SY6Z | AMIODARONE HYDROCHLORIDE | 19774-82-4 | AMIODARONE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2148-3 | 72162214803 | 30 TABLET in 1 BOTTLE (72162-2148-3) | 30 tablet | 2023-12-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pacerone | Bryant Ranch Prepack | 2025-11-05 | HUMAN PRESCRIPTION DRUG LABEL | 101 |
| Pacerone | Bryant Ranch Prepack | 2023-12-07 | HUMAN PRESCRIPTION DRUG LABEL | 100 |