Prescription drug · ANDA
Venlafaxine NDC 70518-3820
Venlafaxine hydrochloride 75 mg/1 · Tablet, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3820-0 | 7051838200070518382000 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3820-0)Marketed from Aug 3, 2023 |
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, Extended release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214127
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-3820_5941cd23-8ee1-95b3-e063-6394a90ab44eSPL ID 5941cd23-8ee1-95b3-e063-6394a90ab44eSPL set ID 1ce5786e-22e6-4afa-8052-6eababc6aa4eRxCUI 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
N470518382000followed by a unit qualifier and the quantityPackage 70518-3820-00. 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 (venlafaxine hydrochloride) 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, represe…
Excerpt only. Read the full label for complete information.
About NDC 70518-3820
- What is NDC 70518-3820?
- 70518-3820 is the product NDC for Venlafaxine, Venlafaxine hydrochloride 75 mg/1 tablet, extended release, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Venlafaxine.
- What is the active ingredient?
- Venlafaxine hydrochloride.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Venlafaxine?
- 118 other product NDCs are listed under this name. See all Venlafaxine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Venlafaxine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4779 | 70518-4779-00 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Coupler LLC | 67046-0560 | 67046-0560-03 |
| venlafaxine | Venlafaxine hydrochloride 50 mg/1 | TabletOral | Coupler LLC | 67046-1681 | 67046-1681-03 |
| venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Coupler LLC | 67046-2020 | 67046-2020-03 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4566 | 70518-4566-00 |
| Venlafaxine | Venlafaxine hydrochloride 150 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4500 | 70518-4500-00 |
| venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4168 | 70518-4168-00 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-323 | 51655-0323-52 |
| Venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-728 | 60760-0728-60 |
| Venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | Tablet, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-221 | 27241-0221-3027241-0221-90 |
Other NDCs under ANDA 214127
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 37.5 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-726 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-727 |
| Venlafaxine | Venlafaxine hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-728 |
| Venlafaxine | Venlafaxine hydrochloride 225 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-729 |
| Venlafaxine | Venlafaxine hydrochloride 150 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4500 |