Venlafaxine Hydrochloride
- Product NDC
- 68788-8837
- 11-digit product format
- 687888837
- Labeler code
- 68788
- Product ID
- 68788-8837_15c77ad7-7edc-4c36-ba3f-3ef05dfb12dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Venlafaxine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA217390
- Marketing category
- ANDA
- Marketing start
- 2025-02-27
- Substance
- VENLAFAXINE HYDROCHLORIDE
- Active strength
- 75 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 Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| VENLAFAXINE HYDROCHLORIDE | 75 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 7D7RX5A8MO |
| Rxcui | 313585 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 7D7RX5A8MO | VENLAFAXINE HYDROCHLORIDE | 99300-78-4 | VENLAFAXINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8837-3 | 68788883703 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8837-3) | 2025-02-27 | No | No | Current |
| 68788-8837-6 | 68788883706 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8837-6) | 2025-02-27 | No | No | Current |
| 68788-8837-9 | 68788883709 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8837-9) | 2025-02-27 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Venlafaxine Hydrochloride | Preferred Pharmaceuticals Inc. | 2025-02-27 | HUMAN PRESCRIPTION DRUG LABEL | 1 |