Ranolazine
- Product NDC
- 42385-964
- 11-digit product format
- 423850964
- Labeler code
- 42385
- Product ID
- 42385-964_dae26a01-bfd7-0432-e053-2995a90a88dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Laurus Generics Inc.
- Application
- ANDA214035
- Marketing category
- ANDA
- Marketing start
- 2022-01-19
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42385-964 | RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [LAURUS GENERICS INC.] | 7 | Legacy NDC | 20250121_3e265b25-81a6-4348-98d7-08df2b5c3b62.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42385-964-60 | 42385096460 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42385-964-60) | 2022-03-01 | 0000-00-00 | No | No | Current |