Ranolazine
- Product NDC
- 71610-518
- 11-digit product format
- 716100518
- Labeler code
- 71610
- Product ID
- 71610-518_1524482d-40bd-a0f9-e063-6394a90a1a37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RANOLAZINE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA212781
- Marketing category
- ANDA
- Marketing start
- 2020-10-27
- 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 |
|---|
| 71610-518-42 | 71610051842 | 1800 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-42) | 2024-04-01 | No | No | Historical |
| 71610-518-83 | 71610051883 | 3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-83) | 2021-01-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ranolazine | Aphena Pharma Solutions - Tennessee, LLC | 2024-04-02 | HUMAN PRESCRIPTION DRUG LABEL | 2 |