ZONTIVITY
- Product NDC
- 70347-208
- 11-digit product format
- 703470208
- Labeler code
- 70347
- Product ID
- 70347-208_bf7831ab-f1fe-9652-e053-2a95a90a6bfd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vorapaxar
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aralez Pharmaceuticals Us Inc.
- Application
- NDA204886
- Marketing category
- NDA
- Marketing start
- 2014-05-08
- Marketing end
- 0000-00-00
- Substance
- VORAPAXAR SULFATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Protease-activated Receptor-1 Antagonist [EPC],Protease-activated Receptor-1 Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70347-208-05 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-48b7-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY. ZONTIVITY ® (vorapaxar) Tablets 2.08 mg*, for oral use *Equivalent to 2.5 mg vorapaxar sulfate Initial U.S. Approval: 2014 |
| 70347-208-30 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-48b7-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY. ZONTIVITY ® (vorapaxar) Tablets 2.08 mg*, for oral use *Equivalent to 2.5 mg vorapaxar sulfate Initial U.S. Approval: 2014 |
| 70347-208-90 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-48b7-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY. ZONTIVITY ® (vorapaxar) Tablets 2.08 mg*, for oral use *Equivalent to 2.5 mg vorapaxar sulfate Initial U.S. Approval: 2014 |
| 70347-208-05 | 2021-04-08 | C162847 | 48780-1 | ba0f9c33-48b7-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY. ZONTIVITY ® (vorapaxar) Tablets 2.08 mg*, for oral use *Equivalent to 2.5 mg vorapaxar sulfate Initial U.S. Approval: 2014 |
| 70347-208-30 | 2021-04-08 | C162847 | 48780-1 | ba0f9c33-48b7-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY. ZONTIVITY ® (vorapaxar) Tablets 2.08 mg*, for oral use *Equivalent to 2.5 mg vorapaxar sulfate Initial U.S. Approval: 2014 |
| 70347-208-90 | 2021-04-08 | C162847 | 48780-1 | ba0f9c33-48b7-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY. ZONTIVITY ® (vorapaxar) Tablets 2.08 mg*, for oral use *Equivalent to 2.5 mg vorapaxar sulfate Initial U.S. Approval: 2014 |
| 70347-208-05 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-48b7-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY. ZONTIVITY ® (vorapaxar) Tablets 2.08 mg*, for oral use *Equivalent to 2.5 mg vorapaxar sulfate Initial U.S. Approval: 2014 |
| 70347-208-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-48b7-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY. ZONTIVITY ® (vorapaxar) Tablets 2.08 mg*, for oral use *Equivalent to 2.5 mg vorapaxar sulfate Initial U.S. Approval: 2014 |
| 70347-208-90 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-48b7-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY. ZONTIVITY ® (vorapaxar) Tablets 2.08 mg*, for oral use *Equivalent to 2.5 mg vorapaxar sulfate Initial U.S. Approval: 2014 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70347-208-05 | ZONTIVITY | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 8 |
| 70347-208-30 | ZONTIVITY | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 70347-208-90 | ZONTIVITY | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70347-208 | ZONTIVITY (VORAPAXAR) TABLET, FILM COATED [ARALEZ PHARMACEUTICALS US INC.] | 8 | Legacy NDC, 3 package rows | 20210409_f001f406-8cf1-40a4-bbf5-1775fe020122.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 |
|---|
| 70347-208-05 | 70347020805 | 5 TABLET, FILM COATED in 1 BLISTER PACK (70347-208-05) | 2017-07-06 | 0000-00-00 | Yes | No | Current |
| 70347-208-30 | 70347020830 | 30 TABLET, FILM COATED in 1 BOTTLE (70347-208-30) | 2017-04-01 | 0000-00-00 | No | No | Current |
| 70347-208-90 | 70347020890 | 90 TABLET, FILM COATED in 1 BOTTLE (70347-208-90) | 2017-04-01 | 0000-00-00 | No | No | Current |