Prescription drug · ANDA
venlafaxine hydrochloride NDC 68071-4442
Venlafaxine hydrochloride 150 mg/1 · Capsule, Extended release · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4442-9 | 68071444209 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4442-9)Marketed from May 21, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- venlafaxine hydrochloride
- Generic name (nonproprietary)
- venlafaxine hydrochloride
- Active ingredients
- Venlafaxine hydrochloride — 150 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090174
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-4442_1a8c4239-97e0-39ec-e063-6394a90a045bSPL ID 1a8c4239-97e0-39ec-e063-6394a90a045bSPL set ID 6cb943a8-5972-292f-e053-2991aa0ae3eeRxCUI 313581UNII 7D7RX5A8MOUPC 0368071444292
- Pharmacologic class
- Serotonin and Norepinephrine Reuptake Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468071444209followed by a unit qualifier and the quantityPackage 68071-4442-09. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Venlafaxine hydrochloride extended-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: Major Depressive Disorder (MDD) Generalized Anxiety Disorder (GAD) Social Anxiety Disorder (SAD) Panic Disorder (PD) 1.1 Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules, USP are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. 1.2 Generalized Anxiety Disorder Venlafaxine hydrochloride extended-release capsules, USP are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090174
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8774 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-6806 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 65841-752 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 65841-751 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 65841-753 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-034 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-035 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-036 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1838 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1836 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1837 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-1699 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-1698 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-1700 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-6301 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-1338 |