Prescription drug · ANDA
Venlafaxine Hydrochloride NDC 63187-481
Venlafaxine hydrochloride 37.5 mg/1 · Capsule, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-481-30 | 63187048130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-481-30)Marketed from May 1, 2015 | |
| 63187-481-60 | 63187048160 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-481-60)Marketed from May 1, 2015 | |
| 63187-481-90 | 63187048190 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-481-90)Marketed from May 1, 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 Hydrochloride
- Generic name (nonproprietary)
- venlafaxine hydrochloride
- Active ingredients
- Venlafaxine hydrochloride — 37.5 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 076565
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-481_e9619c8b-343a-468e-9eb1-9f6a0be2b1f8SPL ID e9619c8b-343a-468e-9eb1-9f6a0be2b1f8SPL set ID adeba7dd-bd15-4d8f-b703-24c3a208e740RxCUI 313583UNII 7D7RX5A8MOUPC 0363187481308
- 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
N463187048130followed by a unit qualifier and the quantityPackage 63187-0481-30. 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)
INDICATIONS AND USAGE Major Depressive Disorder Venlafaxine Hydrochloride Extended-Release Capsules USP are indicated for the treatment of major depressive disorder. The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076565
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 | Teva Pharmaceuticals USA, Inc. | 0093-7384 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-7385 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-7386 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 63187-420 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-6214 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | QPharma, Inc. | 42708-054 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-897 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 63187-177 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-898 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-899 |