venlafaxine
- Product NDC
- 52427-632
- 11-digit product format
- 524270632
- Labeler code
- 52427
- Product ID
- 52427-632_1b0762be-0db0-b997-b76b-b212a496f82c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- venlafaxine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Almatica Pharma LLC
- Application
- NDA215429
- Marketing category
- NDA
- Marketing start
- 2022-06-30
- Substance
- VENLAFAXINE BESYLATE MONOHYDRATE
- Active strength
- 112.5 mg/1
- Pharmacologic classes
- 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
- venlafaxine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VENLAFAXINE BESYLATE MONOHYDRATE | 112.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 18XP3YT5NH |
| Rxcui | 2605950 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52427-632-30 | venlafaxine | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52427-632 | VENLAFAXINE TABLET, EXTENDED RELEASE [ALMATICA PHARMA LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241011_e81a2daf-b8b2-7c05-b532-bc775700b100.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 |
|---|
| 52427-632-30 | 52427063230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52427-632-30) | 2022-08-01 | 0000-00-00 | No | No | Current |