Prescription drug · ANDA
venlafaxine hydrochloride NDC 43598-002
Venlafaxine hydrochloride 150 mg/1 · Capsule, Extended release · Oral · Dr.Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-002-05 | 43598000205 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-05)Marketed from Sep 9, 2024 | |
| 43598-002-30 | 43598000230 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-30)Marketed from Sep 9, 2024 | |
| 43598-002-90 | 43598000290 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-90)Marketed from Sep 9, 2024 |
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 — 150 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Dr.Reddys Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078421
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-002_646ca48a-403a-0ef0-0fc2-a5569c5b70fdSPL ID 646ca48a-403a-0ef0-0fc2-a5569c5b70fdSPL set ID f5c21429-d5d0-9f93-a465-6e5e0e19ebddRxCUI 313581, 313583, 313585UNII 7D7RX5A8MOUPC 0343598001302, 0343598999302
- 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
N443598000205followed by a unit qualifier and the quantityPackage 43598-0002-05. 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 areindicated 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 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.
Other NDCs under ANDA 078421
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 37.5 mg/1 | Capsule, Extended releaseOral | Dr.Reddys Laboratories Inc | 43598-999 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Dr.Reddys Laboratories Inc | 43598-001 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Dr.Reddy's Laboratories Ltd. | 55111-453 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Dr.Reddy's Laboratories Ltd. | 55111-454 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Dr.Reddy's Laboratories Ltd. | 55111-455 |