RANOLAZINE
- Product NDC
- 50228-423
- 11-digit product format
- 502280423
- Labeler code
- 50228
- Product ID
- 50228-423_2a0ac71c-e53c-5ff9-e063-6394a90a4807
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RANOLAZINE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc
- Application
- ANDA211829
- Marketing category
- ANDA
- Marketing start
- 2019-06-04
- 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, 728231 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-423-05 | RANOLAZINE | 500 in 1 PACKAGE | TABLET, FILM COATED, EXTENDED RE | 500 | | 4 |
| 50228-423-30 | RANOLAZINE | 30 in 1 PACKAGE | TABLET, FILM COATED, EXTENDED RE | 30 | | 4 |
| 50228-423-60 | RANOLAZINE | 60 in 1 PACKAGE | TABLET, FILM COATED, EXTENDED RE | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-423 | RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC] | 4 | Current NDC, Legacy NDC, 3 package rows | 20241226_71d50258-75b7-4801-b0f4-c34fe883d57d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50228-423-05 | 50228042305 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (50228-423-05) | 2019-06-04 | 0000-00-00 | No | No | Current |
| 50228-423-30 | 50228042330 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (50228-423-30) | 2019-06-04 | 0000-00-00 | No | No | Current |
| 50228-423-60 | 50228042360 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (50228-423-60) | 2019-06-04 | 0000-00-00 | No | No | Current |