Ranolazine
- Product NDC
- 0615-8611
- 11-digit product format
- 006158611
- Labeler code
- 0615
- Product ID
- 0615-8611_1a937beb-d2a1-4ea1-8e06-e0c87b357168
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA210188
- Marketing category
- ANDA
- Marketing start
- 2019-09-10
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ranolazine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RANOLAZINE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A6IEZ5M406 |
| Rxcui | 616749 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8611-39 | Ranolazine | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8611-39 | 00615861139 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8611-39) | 2026-01-14 | No | No | Historical |