Ranolazine
- Product NDC
- 63629-4874
- 11-digit product format
- 636294874
- Labeler code
- 63629
- Product ID
- 63629-4874_ef5432b9-f1d1-4166-a264-337420d7ec04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ranolazine
- Listing expiration
- 2026-12-31
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 |
|---|
| 63629-4874-1 | Ranolazine | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-4874 | RANOLAZINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 1 | Current NDC, 1 package rows | 20250119_2e678c80-1410-433b-8c48-4b210eceb0de.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-4874-1 | 63629487401 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4874-1) | 2025-01-17 | No | No | Historical |