Prescription drug · ANDA
venlafaxine NDC 71335-0778
Venlafaxine hydrochloride 75 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0778-1 | 71335077801 | 60 TABLET in 1 BOTTLE (71335-0778-1)Marketed from Feb 9, 2022 | |
| 71335-0778-2 | 71335077802 | 30 TABLET in 1 BOTTLE (71335-0778-2)Marketed from Feb 9, 2022 | |
| 71335-0778-3 | 71335077803 | 90 TABLET in 1 BOTTLE (71335-0778-3)Marketed from Feb 9, 2022 | |
| 71335-0778-4 | 71335077804 | 28 TABLET in 1 BOTTLE (71335-0778-4)Marketed from Feb 9, 2022 | |
| 71335-0778-5 | 71335077805 | 120 TABLET in 1 BOTTLE (71335-0778-5)Marketed from Feb 9, 2022 | |
| 71335-0778-6 | 71335077806 | 100 TABLET in 1 BOTTLE (71335-0778-6)Marketed from Feb 9, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078932
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-0778_a90443c0-5875-46af-857d-1fdae8c8ad0eSPL ID a90443c0-5875-46af-857d-1fdae8c8ad0eSPL set ID 0c9511a2-c581-44cd-bf38-a751fcc658e4RxCUI 313586UNII 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
N471335077801followed by a unit qualifier and the quantityPackage 71335-0778-01. 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 are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets 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 include at lea…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078932
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 25 mg/1 | TabletOral | Proficient Rx LP | 82804-124 |
| venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | St Mary's Medical Park Pharmacy | 60760-713 |
| venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3643 |
| venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | A-S Medication Solutions | 50090-4715 |
| venlafaxine | Venlafaxine hydrochloride 100 mg/1 | TabletOral | Proficient Rx LP | 63187-752 |
| venlafaxine | Venlafaxine hydrochloride 100 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-717 |
| venlafaxine | Venlafaxine hydrochloride 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3433 |
| venlafaxine | Venlafaxine hydrochloride 25 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-008 |
| venlafaxine | Venlafaxine hydrochloride 100 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-012 |
| venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-009 |
| venlafaxine | Venlafaxine hydrochloride 50 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-010 |
| venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-011 |
| venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-332 |
| venlafaxine | Venlafaxine hydrochloride 25 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-430 |
| venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-431 |
| venlafaxine | Venlafaxine hydrochloride 50 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-432 |
| venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-433 |
| venlafaxine | Venlafaxine hydrochloride 100 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-434 |
| venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4168 |
| venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Proficient Rx LP | 63187-929 |
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