RANOLAZINE
- Product NDC
- 48792-7893
- 11-digit product format
- 487927893
- Labeler code
- 48792
- Product ID
- 48792-7893_a2238db8-81c5-06be-e053-2a95a90a5cf8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ranolazine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sunshine Lake Pharma Co., Ltd.
- Application
- ANDA211865
- Marketing category
- ANDA
- Marketing start
- 2020-03-31
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 48792-7893-1 | 48792789301 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (48792-7893-1) | 2020-03-31 | 0000-00-00 | No | No | Current |