Prescription drug · ANDA
Venlafaxine NDC 72241-075
Venlafaxine hydrochloride 75 mg/1 · Tablet, Coated · Oral · Modavar Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72241-075-04 | 72241007504 | 90 TABLET, COATED in 1 BOTTLE (72241-075-04)Marketed from Aug 16, 2018 | |
| 72241-075-11 | 72241007511 | 1000 TABLET, COATED in 1 BOTTLE (72241-075-11)Marketed from Aug 16, 2018 | |
| 72241-075-22 | 72241007522 | 30 TABLET, COATED in 1 BOTTLE (72241-075-22)Marketed from Aug 16, 2018 |
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, Coated
- Route
- Oral
- Labeler
- Modavar Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211323
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 72241-075_14b38374-7287-47dd-8ef9-e88bd5b23a26SPL ID 14b38374-7287-47dd-8ef9-e88bd5b23a26SPL set ID 14b38374-7287-47dd-8ef9-e88bd5b23a26RxCUI 808744, 808748, 808753UNII 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
N472241007504followed by a unit qualifier and the quantityPackage 72241-0075-04. 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 extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1.1 ) Social Anxiety Disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder Venlafaxine extended-release tablets are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [see Clinical Studies ( 14.1 )] . 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 change from previo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211323
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 225 mg/1 | Tablet, CoatedOral | Cadila Pharmaceuticals Limited | 71209-089 |
| Venlafaxine | Venlafaxine hydrochloride 150 mg/1 | Tablet, CoatedOral | Modavar Pharmaceuticals LLC | 72241-076 |
| Venlafaxine | Venlafaxine hydrochloride 225 mg/1 | Tablet, CoatedOral | Modavar Pharmaceuticals LLC | 72241-077 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Nivagen Pharmaceuticals, Inc. | 75834-217 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Nivagen Pharmaceuticals, Inc. | 75834-218 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 225 mg/1 | Tablet, Extended releaseOral | Nivagen Pharmaceuticals, Inc. | 75834-219 |
| Venlafaxine | Venlafaxine hydrochloride 150 mg/1 | Tablet, CoatedOral | Cadila Pharmaceuticals Limited | 71209-088 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | Tablet, CoatedOral | Cadila Pharmaceuticals Limited | 71209-087 |