Desvenlafaxine
- Product NDC
- 46708-542
- 11-digit product format
- 467080542
- Labeler code
- 46708
- Product ID
- 46708-542_162ec8ed-f695-4db2-badf-4afb6b9e1cba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desvenlafaxine Succinate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA204003
- Marketing category
- ANDA
- Marketing start
- 2018-09-14
- Substance
- DESVENLAFAXINE SUCCINATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Desvenlafaxine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DESVENLAFAXINE SUCCINATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZB22ENF0XR |
| Rxcui | 1607617, 1874553, 1874559 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-542-10 | 2023-02-01 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
| 46708-542-30 | 2023-02-01 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
| 46708-542-31 | 2023-02-01 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
| 46708-542-80 | 2023-02-01 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
| 46708-542-90 | 2023-02-01 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
| 46708-542-91 | 2023-02-01 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
| 46708-542-10 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
| 46708-542-30 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
| 46708-542-31 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
| 46708-542-80 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
| 46708-542-90 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
| 46708-542-91 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2b96-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use. Initial U.S. Approval: 2008 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-542-10 | Desvenlafaxine | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | | 5 |
| 46708-542-30 | Desvenlafaxine | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 5 |
| 46708-542-31 | Desvenlafaxine | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 5 |
| 46708-542-80 | Desvenlafaxine | 80 in 1 CARTON | TABLET, EXTENDED RELEASE | 80 | | 5 |
| 46708-542-90 | Desvenlafaxine | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 5 |
| 46708-542-91 | Desvenlafaxine | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-542 | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 5 | Current NDC, Legacy NDC, 6 package rows | 20230202_5bd203d2-477e-4d12-a875-cb8009f42410.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 |
|---|
| 46708-542-10 | 46708054210 | 100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-542-10) | 2018-09-14 | 0000-00-00 | No | No | Current |
| 46708-542-30 | 46708054230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-30) | 2018-09-14 | 0000-00-00 | No | No | Current |
| 46708-542-31 | 46708054231 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-31) | 2018-09-14 | 0000-00-00 | No | No | Current |
| 46708-542-80 | 46708054280 | 80 TABLET, EXTENDED RELEASE in 1 CARTON (46708-542-80) | 2018-09-14 | 0000-00-00 | No | No | Current |
| 46708-542-90 | 46708054290 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-90) | 2018-09-14 | 0000-00-00 | No | No | Current |
| 46708-542-91 | 46708054291 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-91) | 2018-09-14 | 0000-00-00 | No | No | Current |