RANOLAZINE
- Product NDC
- 77771-424
- 11-digit product format
- 777710424
- Labeler code
- 77771
- Product ID
- 77771-424_2db3da6f-14f6-4c55-ad22-55e475ad9f09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RANOLAZINE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Radha Pharmaceuticals, Inc
- Application
- ANDA211829
- Marketing category
- ANDA
- Marketing start
- 2025-06-30
- Substance
- RANOLAZINE
- Active strength
- 1000 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 | 1000 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 |
|---|
| 77771-424-60 | RANOLAZINE | 60 in 1 PACKAGE | TABLET, FILM COATED, EXTENDED RE | 60 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 77771-424-60 | 77771042460 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (77771-424-60) | 2025-06-30 | No | No | Historical |