Prescription drug · ANDA
Venlafaxine NDC 68382-020
Venlafaxine hydrochloride 50 mg/1 · Tablet · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-020-01 | 68382002001 | 100 TABLET in 1 BOTTLE (68382-020-01)Marketed from Jun 13, 2008 | |
| 68382-020-05 | 68382002005 | 500 TABLET in 1 BOTTLE (68382-020-05)Marketed from Jun 13, 2008 | |
| 68382-020-06 | 68382002006 | 30 TABLET in 1 BOTTLE (68382-020-06)Marketed from Jun 13, 2008 | |
| 68382-020-10 | 68382002010 | 1000 TABLET in 1 BOTTLE (68382-020-10)Marketed from Jun 13, 2008 | |
| 68382-020-14 | 68382002014 | 60 TABLET in 1 BOTTLE (68382-020-14)Marketed from Jun 13, 2008 | |
| 68382-020-16 | 68382002016 | 90 TABLET in 1 BOTTLE (68382-020-16)Marketed from Jun 13, 2008 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077653
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68382-020_ea404f6c-7e07-4779-a52c-8cffb92718efSPL ID ea404f6c-7e07-4779-a52c-8cffb92718efSPL set ID 72efad5f-0909-46a5-aa13-ac24fe015fe6RxCUI 313580, 313582, 313584, 313586, 314277UNII 7D7RX5A8MOUPC 0368382019011, 0368382018014, 0368382021014, 0368382101013
- 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
N468382002001followed by a unit qualifier and the quantityPackage 68382-0020-01. 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 are 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 incl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077653
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 | TabletOral | Zydus Lifesciences Limited | 65841-674 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-671 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-672 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-673 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-675 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3324 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2990 |
| Venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-728 |
| Venlafaxine | Venlafaxine hydrochloride 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2709 |
| Venlafaxine | Venlafaxine hydrochloride 100 mg/1 | TabletOral | BluePoint Laboratories | 68001-156 |
| Venlafaxine | Venlafaxine hydrochloride 50 mg/1 | TabletOral | BluePoint Laboratories | 68001-159 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Proficient Rx LP | 63187-414 |
| Venlafaxine | Venlafaxine hydrochloride 25 mg/1 | TabletOral | BluePoint Laboratories | 68001-157 |
| Venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | BluePoint Laboratories | 68001-158 |
| Venlafaxine | Venlafaxine hydrochloride 25 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-018 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | BluePoint Laboratories | 68001-160 |
| Venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-019 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-021 |
| Venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | American Health Packaging | 68084-844 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | American Health Packaging | 68084-856 |
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