Ranolazine
- Product NDC
- 60687-549
- 11-digit product format
- 606870549
- Labeler code
- 60687
- Product ID
- 60687-549_23955366-9210-f95f-e063-6394a90a7e99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA210054
- Marketing category
- ANDA
- Marketing start
- 2020-08-19
- 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 |
|---|
| 60687-549-21 | 60687054921 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-549-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-549-11) | 30 blister pack | 2020-08-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ranolazine | American Health Packaging | 2024-10-03 | HUMAN PRESCRIPTION DRUG LABEL | 3 |