Ranexa
- Product NDC
- 43353-880
- 11-digit product format
- 433530880
- Labeler code
- 43353
- Product ID
- 43353-880_d39e6df1-44b6-46a3-9da7-250f6a589b01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RANOLAZINE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA021526
- Marketing category
- NDA
- Marketing start
- 2006-01-27
- Marketing end
- 0000-00-00
- Substance
- RANOLAZINE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 43353-880 | RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC | 20160803_4299062a-b208-4e08-93ec-a05894541c07.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-880-83 | 43353088083 | 3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-880-83) | 2016-01-06 | 0000-00-00 | No | No | Current |