Ranolazine
- Product NDC
- 67877-525
- 11-digit product format
- 678770525
- Labeler code
- 67877
- Product ID
- 67877-525_05aa3d63-f0b2-4aff-8c82-847eec936579
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA209953
- Marketing category
- ANDA
- Marketing start
- 2020-12-02
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ranolazine
- Listing expiration
- 2026-12-31
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 |
|---|
| 67877-525-10 | Ranolazine | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 6 |
| 67877-525-38 | Ranolazine | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 6 |
| 67877-525-38 | Ranolazine | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | | 6 |
| 67877-525-60 | Ranolazine | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-525 | RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [ASCEND LABORATORIES, LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20220928_5b254a8e-db88-49be-bb48-e6d2847f8ab3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-525-10 | 67877052510 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-525-10) | | 2020-12-02 | 0000-00-00 | No | No | Current |
| 67877-525-38 | 67877052538 | 10 BLISTER PACK in 1 CARTON (67877-525-38) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2020-12-02 | 0000-00-00 | No | No | Current |
| 67877-525-60 | 67877052560 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-525-60) | | 2020-12-02 | 0000-00-00 | No | No | Current |