Pacerone
- Product NDC
- 0245-0145
- 11-digit product format
- 002450145
- Labeler code
- 0245
- Product ID
- 0245-0145_7c5ce47c-8219-49a8-a958-e2b7a7ff68d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA075315
- Marketing category
- ANDA
- Marketing start
- 2000-06-30
- Marketing end
- 0000-00-00
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 400 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
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0245-0145-01 | 00245014501 | 100 BLISTER PACK in 1 CARTON (0245-0145-01) > 1 TABLET in 1 BLISTER PACK (0245-0145-89) | 100 blister pack | 2000-06-30 | 0000-00-00 | No | No | Current |
| 0245-0145-15 | 00245014515 | 500 TABLET in 1 BOTTLE (0245-0145-15) | 500 tablet | 2000-06-30 | 2023-09-30 | No | No | Current |
| 0245-0145-30 | 00245014530 | 30 TABLET in 1 BOTTLE (0245-0145-30) | 30 tablet | 2000-06-30 | 2023-09-30 | No | No | Current |