Ranolazine
- Product NDC
- 0904-7506
- 11-digit product format
- 009047506
- Labeler code
- 0904
- Product ID
- 0904-7506_655f85d1-ebab-4b44-8619-2a54b34724a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA209953
- Marketing category
- ANDA
- Marketing start
- 2025-01-17
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7506-04 | 00904750604 | 30 BLISTER PACK in 1 CARTON (0904-7506-04) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 30 blister pack | 2025-01-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ranolazine | Major Pharmaceuticals | 2025-12-29 | HUMAN PRESCRIPTION DRUG LABEL | 2 |