sorafenib
- Product NDC
- 51990-201
- 11-digit product format
- 519900201
- Labeler code
- 51990
- Product ID
- 51990-201_4685d90a-e8e2-5c01-e063-6294a90a1439
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sorafenib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Yabao Pharmaceutical Co., Ltd. Beijing
- Application
- ANDA209050
- Marketing category
- ANDA
- Marketing start
- 2022-12-01
- Substance
- SORAFENIB
- Active strength
- 200 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Protein Kinase 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
- sorafenib
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SORAFENIB | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9ZOQ3TZI87 |
| Rxcui | 597747 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 51990-201-06 | 2024-02-18 | C162847 | 48780-1 | 1030e365-279a-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 |
| 51990-201-06 | 2024-02-18 | C162847 | 48780-1 | 1030e365-279a-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 |
| 51990-201-12 | 2024-02-18 | C162847 | 48780-1 | 1030e365-279a-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 |
| 51990-201-12 | 2024-02-18 | C162847 | 48780-1 | 1030e365-279a-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 |
| 51990-201-06 | 2024-01-30 | C162847 | 48780-1 | 1030e365-279a-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 |
| 51990-201-06 | 2024-01-30 | C162847 | 48780-1 | 1030e365-279a-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 |
| 51990-201-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-279a-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 |
| 51990-201-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-279a-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51990-201-06 | sorafenib | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 9 |
| 51990-201-12 | sorafenib | 120 in 1 PACKAGE | TABLET, FILM COATED | 120 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51990-201 | SORAFENIB TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241208_06f442d6-071e-4081-b7f7-40f3b803ab3f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51990-201-06 | 51990020106 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51990-201-06) | 2022-12-01 | 0000-00-00 | No | No | Current |
| 51990-201-12 | 51990020112 | 120 TABLET, FILM COATED in 1 PACKAGE (51990-201-12) | 2022-12-01 | 0000-00-00 | No | No | Current |