Desvenlafaxine
- Product NDC
- 51991-311
- 11-digit product format
- 519910311
- Labeler code
- 51991
- Product ID
- 51991-311_34b890a1-3d88-43fb-b54b-f168ae22ebc7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desvenlafaxine Succinate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc
- Application
- ANDA204003
- Marketing category
- ANDA
- Marketing start
- 2017-03-01
- Substance
- DESVENLAFAXINE SUCCINATE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZB22ENF0XR |
| Rxcui | 1607617, 1874553, 1874559 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51991-311-01 | Desvenlafaxine | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 23 |
| 51991-311-10 | Desvenlafaxine | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 23 |
| 51991-311-11 | Desvenlafaxine | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | | 23 |
| 51991-311-14 | Desvenlafaxine | 14 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 14 | | 23 |
| 51991-311-33 | Desvenlafaxine | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 23 |
| 51991-311-80 | Desvenlafaxine | 80 in 1 CARTON | TABLET, EXTENDED RELEASE | 80 | | 23 |
| 51991-311-90 | Desvenlafaxine | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DESVENLAFAXINE SUCCINATE | ACTIVE INGREDIENT | ZB22ENF0XR | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
| DESVENLAFAXINE | ACTIVE MOIETY | NG99554ANW | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-311 | DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC] | 23 | Current NDC, Legacy NDC, 7 package rows | 20241004_25bdfc41-c7cb-4d16-b6a8-f102f9b8c984.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 |
|---|
| 51991-311-01 | 51991031101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-311-01) | 2017-03-01 | 0000-00-00 | No | No | Current |
| 51991-311-10 | 51991031110 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-311-10) | 2017-03-01 | 0000-00-00 | No | No | Current |
| 51991-311-11 | 51991031111 | 100 TABLET, EXTENDED RELEASE in 1 CARTON (51991-311-11) | 2017-03-01 | 0000-00-00 | No | No | Current |
| 51991-311-14 | 51991031114 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-311-14) | 2017-03-01 | 0000-00-00 | No | No | Current |
| 51991-311-33 | 51991031133 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-311-33) | 2017-03-01 | 0000-00-00 | No | No | Current |
| 51991-311-80 | 51991031180 | 80 TABLET, EXTENDED RELEASE in 1 CARTON (51991-311-80) | 2017-03-01 | 0000-00-00 | No | No | Current |
| 51991-311-90 | 51991031190 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-311-90) | 2017-03-01 | 0000-00-00 | No | No | Current |