Prescription drug · ANDA
Venlafaxine Hydrochloride NDC 46708-792
Venlafaxine hydrochloride 37.5 mg/1 · Capsule, Extended release · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-792-30 | 46708079230 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-792-30)Marketed from Jun 10, 2024 | |
| 46708-792-31 | 46708079231 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-792-31)Marketed from Jun 10, 2024 | |
| 46708-792-71 | 46708079271 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-792-71)Marketed from Jun 10, 2024 | |
| 46708-792-90 | 46708079290 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-792-90)Marketed from Jun 10, 2024 | |
| 46708-792-91 | 46708079291 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-792-91)Marketed from Jun 10, 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 — 37.5 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217767
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-792_e3e238db-4388-49bb-aa67-6d73adbb2280SPL ID e3e238db-4388-49bb-aa67-6d73adbb2280SPL set ID e3e238db-4388-49bb-aa67-6d73adbb2280RxCUI 313581, 313583, 313585UNII 7D7RX5A8MOUPC 0346708794309
- 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
N446708079230followed by a unit qualifier and the quantityPackage 46708-0792-30. 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)
Venlafaxine hydrochloride extended-release capsules are indicated 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 a 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 217767
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 | NorthStar RxLLC | 72603-747 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-748 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-749 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-792 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-793 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-794 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-794 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-793 |