Prescription drug · ANDA
Venlafaxine NDC 43063-633
Venlafaxine hydrochloride 75 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-633-90 | 43063063390 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-633-90)Marketed from Nov 25, 2015 |
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
- Generic name (nonproprietary)
- venlafaxine
- Active ingredients
- Venlafaxine hydrochloride — 75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078627
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 43063-633_51176701-749d-f1ac-e063-6294a90ad140SPL ID 51176701-749d-f1ac-e063-6294a90ad140SPL set ID 18495527-add4-42a5-bbf7-9f8dc2df06afRxCUI 313586UNII 7D7RX5A8MOUPC 0343063633908
- 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
N443063063390followed by a unit qualifier and the quantityPackage 43063-0633-90. 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)
INDICATIONS AND USAGE Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should inclu…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078627
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 | Venlafaxine hydrochloride 50 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-394 |
| Venlafaxine | Venlafaxine hydrochloride 25 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-392 |
| Venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-393 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-395 |
| Venlafaxine | Venlafaxine hydrochloride 100 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-396 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-606 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-456 |
| Venlafaxine | Venlafaxine hydrochloride 25 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-453 |
| Venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-454 |
| Venlafaxine | Venlafaxine hydrochloride 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-455 |
| Venlafaxine | Venlafaxine hydrochloride 100 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-457 |