Prescription drug · ANDA
Venlafaxine Hydrochloride NDC 0615-8509
Venlafaxine hydrochloride 75 mg/1 · Capsule, Extended release · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8509-39 | 0061585093900615850939 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8509-39)Marketed from May 16, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217390
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0615-8509_f4c48a47-b134-4ed0-a838-0af90d59dc5dSPL ID f4c48a47-b134-4ed0-a838-0af90d59dc5dSPL set ID 9c061460-3b80-41e1-a87a-1a25108ff740RxCUI 313581, 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
N400615850939followed by a unit qualifier and the quantityPackage 00615-8509-39. 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 indicated in adults for the treatment of: • Major Depressive Disorder (MDD) [ see Clinical Studies (14.1) ] • Generalized Anxiety Disorder (GAD) [ see Clinical Studies (14.2) ] • Social Anxiety Disorder (SAD) [ see Clinical Studies (14.3) ] • Panic Disorder (PD) [ see Clinical Studies (14.4) ] Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: Major Depressive Disorder (MDD) ( 1 ) Generalized Anxiety Disorder (GAD) ( 1 ) Social Anxiety Disorder (SAD) ( 1 ) Panic Disorder (PD) ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0615-8509
- What is NDC 0615-8509?
- 0615-8509 is the product NDC for Venlafaxine Hydrochloride, Venlafaxine hydrochloride 75 mg/1 capsule, extended release, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Venlafaxine Hydrochloride.
- What is the active ingredient?
- Venlafaxine hydrochloride.
- Who is the labeler?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Venlafaxine Hydrochloride?
- 207 other product NDCs are listed under this name. See all Venlafaxine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Venlafaxine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-125 | 24658-0125-1024658-0125-3024658-0125-90 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-126 | 24658-0126-1024658-0126-3024658-0126-90 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-127 | 24658-0127-0524658-0127-3024658-0127-90 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-0390 | 67046-0390-03 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-0527 | 67046-0527-03 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-747 | 72603-0747-01 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-748 | 72603-0748-01 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-749 | 72603-0749-01 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4632 | 70518-4632-00 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Advanced Rx of Tennessee, LLC | 80425-0581 | 80425-0581-0180425-0581-0280425-0581-03 |
Other NDCs under ANDA 217390
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8510 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-1656 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | NuCare Pharmaceuticals Inc. | 68071-3727 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8837 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-184 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-185 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-186 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4632 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2779 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2971 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2992 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Advanced Rx of Tennessee, LLC | 80425-0472 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Advanced Rx of Tennessee, LLC | 80425-0581 |