Prescription drug · ANDA
Venlafaxine Hydrochloride NDC 71205-369
Venlafaxine hydrochloride 75 mg/1 · Capsule, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-369-30 | 71205036930 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-369-30)Marketed from Dec 3, 2019 | |
| 71205-369-60 | 71205036960 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-369-60)Marketed from Dec 3, 2019 | |
| 71205-369-90 | 71205036990 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-369-90)Marketed from Dec 3, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 75 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200834
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-369_61d97d27-06ed-49a4-9514-f02684521d4bSPL ID 61d97d27-06ed-49a4-9514-f02684521d4bSPL set ID 18e77a42-6552-4042-9ed3-046c94f4f921RxCUI 313585UNII 7D7RX5A8MO
- 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
N471205036930followed by a unit qualifier and the quantityPackage 71205-0369-30. 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 are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: • Major Depressive Disorder ( MDD ) • Social Anxiety Disorder ( SAD ) • Generalized Anxiety Disorder ( GAD ) • Panic Disorder ( PD ) 1.1 Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules 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 are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy wa…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200834
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 75 mg/1 | Capsule, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3886 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-7940 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Major Pharmaceuticals | 0904-7489 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-058 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-056 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-057 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Asclemed USA, Inc. | 76420-632 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Asclemed USA, Inc. | 76420-630 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Asclemed USA, Inc. | 76420-631 |
| Venlafaxine HCL ER | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Direct_Rx | 72189-414 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 65862-697 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | QPharma, Inc. | 42708-194 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-2107 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8140 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-5160 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-2259 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-1864 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-0527 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 71205-408 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | American Health Packaging | 68084-698 |
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