Venlafaxine Hydrochloride
- Product NDC
- 58118-0096
- 11-digit product format
- 581180096
- Labeler code
- 58118
- Product ID
- 58118-0096_8d8245eb-7005-111d-e053-2995a90af73a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Venlafaxine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA076565
- Marketing category
- ANDA
- Marketing start
- 2010-07-01
- Marketing end
- 0000-00-00
- Substance
- VENLAFAXINE HYDROCHLORIDE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 17db3736-056c-48b9-b0f4-00fccabb14e6 | Product name | 5 | 20251118 |
| 7be8b949-f2c0-bdd8-e89d-8af92c1b2ead | Product name | 9 | 20250224 |
| b1435b59-059c-404b-a587-53656bf80e17 | Product name | 1 | 20230314 |
| 6005cd75-f7b1-d6be-3cb5-4bd30d5c4617 | Product name | 3 | 20190314 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58118-0096-8 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-12f6-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use venlafaxine hydrochloride extended-release capsules USP safely and effectively. See full prescribing information for venlafaxine hydrochloride extended-release capsules USP. VENLAFAXINE hydrochloride extended-release capsules USP, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58118-0096-8 | Venlafaxine Hydrochloride | 30 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 30 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58118-0096 | VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC] | 6 | Legacy NDC, 1 package rows | 20190713_22fc7a97-5b01-4e31-aee2-d3507e46ed84.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313581 | venlafaxine HCl 150 MG 24HR Extended Release Oral Capsule | PSN | 22fc7a97-5b01-4e31-aee2-d3507e46ed84 | 6 |
| 313583 | venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule | PSN | 22fc7a97-5b01-4e31-aee2-d3507e46ed84 | 6 |
| 313585 | venlafaxine HCl 75 MG 24HR Extended Release Oral Capsule | PSN | 22fc7a97-5b01-4e31-aee2-d3507e46ed84 | 6 |
| 313581 | 24 HR venlafaxine 150 MG Extended Release Oral Capsule | SCD | 22fc7a97-5b01-4e31-aee2-d3507e46ed84 | 6 |
| 313583 | 24 HR venlafaxine 37.5 MG Extended Release Oral Capsule | SCD | 22fc7a97-5b01-4e31-aee2-d3507e46ed84 | 6 |
| 313585 | 24 HR venlafaxine 75 MG Extended Release Oral Capsule | SCD | 22fc7a97-5b01-4e31-aee2-d3507e46ed84 | 6 |
| 313581 | venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral Capsule | SY | 22fc7a97-5b01-4e31-aee2-d3507e46ed84 | 6 |
| 313583 | venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule | SY | 22fc7a97-5b01-4e31-aee2-d3507e46ed84 | 6 |
| 313585 | venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral Capsule | SY | 22fc7a97-5b01-4e31-aee2-d3507e46ed84 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 58118-0096-8 | 58118009608 | 30 in 1 BLISTER PACK | Historical |