Ranolazine
- Product NDC
- 45963-418
- 11-digit product format
- 459630418
- Labeler code
- 45963
- Product ID
- 45963-418_62402145-6094-4c6b-b622-ffa3fb76651d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA208862
- Marketing category
- ANDA
- Marketing start
- 2019-05-28
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45963-418-06 | Ranolazine | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 9 |
| 45963-418-50 | Ranolazine | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45963-418 | RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 8 | Legacy NDC, 2 package rows | 20230306_896ea7ab-8714-4e8b-a194-5b0bde318032.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45963-418-06 | 45963041806 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-418-06) | 2019-05-28 | 0000-00-00 | No | No | Current |
| 45963-418-50 | 45963041850 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-418-50) | 2019-05-28 | 0000-00-00 | No | No | Current |