Ranolazine
- Product NDC
- 82804-118
- 11-digit product format
- 828040118
- Labeler code
- 82804
- Product ID
- 82804-118_c7ed8234-e6bd-4f19-a1ce-40f272a79036
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA211829
- Marketing category
- ANDA
- Marketing start
- 2021-08-24
- Substance
- RANOLAZINE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 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 |
|---|
| A6IEZ5M406 | RANOLAZINE | 95635-55-5 | RANOLAZINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-118-60 | 82804011860 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-118-60) | 2024-07-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ranolazine | Proficient Rx LP | 2024-07-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |