Desvenlafaxine
- Product NDC
- 63629-7524
- 11-digit product format
- 636297524
- Labeler code
- 63629
- Product ID
- 63629-7524_9f976ef0-7c5a-4b5a-bca2-5fecdd4006cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desvenlafaxine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204082
- Marketing category
- ANDA
- Marketing start
- 2017-08-29
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Desvenlafaxine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DESVENLAFAXINE SUCCINATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZB22ENF0XR |
| Rxcui | 1607617 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 63629-7524-1 | 2024-05-16 | C162847 | 48780-1 | 1030e365-37bf-111a-e063-dadaa90a10e2 | 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 |
| 63629-7524-2 | 2024-05-16 | C162847 | 48780-1 | 1030e365-37bf-111a-e063-dadaa90a10e2 | 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 |
| 63629-7524-3 | 2024-05-16 | C162847 | 48780-1 | 1030e365-37bf-111a-e063-dadaa90a10e2 | 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 |
| 63629-7524-4 | 2024-05-16 | C162847 | 48780-1 | 1030e365-37bf-111a-e063-dadaa90a10e2 | 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 |
| 63629-7524-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-37bf-111a-e063-dadaa90a10e2 | 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 |
| 63629-7524-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-37bf-111a-e063-dadaa90a10e2 | 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 |
| 63629-7524-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-37bf-111a-e063-dadaa90a10e2 | 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 |
| 63629-7524-4 | 2024-01-30 | C162847 | 48780-1 | 1030e365-37bf-111a-e063-dadaa90a10e2 | 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 |
|---|
| 63629-7524-1 | Desvenlafaxine | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 1005 |
| 63629-7524-2 | Desvenlafaxine | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 1005 |
| 63629-7524-3 | Desvenlafaxine | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 1005 |
| 63629-7524-4 | Desvenlafaxine | 120 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 120 | | 1005 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-7524 | DESVENLAFAXINE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 1004 | Current NDC, Legacy NDC, 4 package rows | 20250221_d585d916-2a5d-4baa-9c64-52b12313aba3.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 |
|---|
| 63629-7524-1 | 63629752401 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-7524-1) | 2025-01-24 | 0000-00-00 | No | No | Current |
| 63629-7524-2 | 63629752402 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-7524-2) | 2025-01-24 | 0000-00-00 | No | No | Current |
| 63629-7524-3 | 63629752403 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-7524-3) | 2025-01-24 | 0000-00-00 | No | No | Current |
| 63629-7524-4 | 63629752404 | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-7524-4) | 2025-01-24 | 0000-00-00 | No | No | Current |