Ranolazine
- Product NDC
- 70625-206
- 11-digit product format
- 706250206
- Labeler code
- 70625
- Product ID
- 70625-206_4dd57879-c7db-7079-e063-6294a90abcf7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RANOLAZINE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- SunGen Pharma LLC
- Application
- ANDA212781
- Marketing category
- ANDA
- Marketing start
- 2020-04-01
- 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
- 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 | 500 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 |
|---|
| 70625-206-00 | Ranolazine | 29125 in 1 BOX | TABLET, FILM COATED, EXTENDED RE | 29125 | | 14 |
| 70625-206-01 | Ranolazine | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 14 |
| 70625-206-02 | Ranolazine | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70625-206 | RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [SUNGEN PHARMA LLC] | 12 | Current NDC, Legacy NDC, 3 package rows | 20250331_f3c09979-a44a-4197-97d2-29a207b6fc73.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70625-206-00 | 70625020600 | 29125 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOX (70625-206-00) | 2020-04-01 | | No | No | Current |
| 70625-206-01 | 70625020601 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70625-206-01) | 2020-04-01 | 0000-00-00 | No | No | Current |
| 70625-206-02 | 70625020602 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70625-206-02) | 2020-04-01 | 0000-00-00 | No | No | Current |