Prescription drug · ANDA
Venlafaxine Hydrochloride (Venlafaxine) NDC 68001-498
Venlafaxine hydrochloride 150 mg/1 · Tablet, Extended release · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-498-04 | 6800104980468001049804 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-498-04)Marketed from Apr 30, 2021 |
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
- Active ingredients
- Venlafaxine hydrochloride — 150 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- BluePoint LaboratoriesNDC labeler code 68001
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214419
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68001-498_2b5c3dc6-9055-abe9-e063-6294a90af76eSPL ID 2b5c3dc6-9055-abe9-e063-6294a90af76eSPL set ID 5efe1336-c796-4560-8110-a64c80eefb0cRxCUI 808744, 808748, 808751, 808753UNII 7D7RX5A8MOUPC 0368001499040, 0368001498043, 0368001496049, 0368001497046
- 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
N468001049804followed by a unit qualifier and the quantityPackage 68001-0498-04. 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 previ…
Excerpt only. Read the full label for complete information.
About NDC 68001-498
- What is NDC 68001-498?
- 68001-498 is the product NDC for Venlafaxine Hydrochloride (venlafaxine), Venlafaxine hydrochloride 150 mg/1 tablet, extended release, listed with the FDA by BluePoint Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Venlafaxine Hydrochloride (Venlafaxine).
- What is the active ingredient?
- Venlafaxine hydrochloride.
- Who is the labeler?
- BluePoint Laboratories, NDC labeler code 68001. 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 Hydrochloride?
- 207 other product NDCs are listed under this name. See all Venlafaxine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Venlafaxine Hydrochloride 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 Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-125 | 24658-0125-1024658-0125-3024658-0125-90 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-126 | 24658-0126-1024658-0126-3024658-0126-90 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-127 | 24658-0127-0524658-0127-3024658-0127-90 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-0390 | 67046-0390-03 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-0527 | 67046-0527-03 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-747 | 72603-0747-01 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-748 | 72603-0748-01 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-749 | 72603-0749-01 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4632 | 70518-4632-00 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Advanced Rx of Tennessee, LLC | 80425-0581 | 80425-0581-0180425-0581-0280425-0581-03 |
Other NDCs under ANDA 214419
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 Hydrochloridevenlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-123 |
| Venlafaxine Hydrochloridevenlafaxine | Venlafaxine hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-124 |
| Venlafaxine Hydrochloridevenlafaxine | Venlafaxine hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-125 |
| Venlafaxine Hydrochloridevenlafaxine | Venlafaxine hydrochloride 225 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-126 |
| Venlafaxine Hydrochloridevenlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-496 |
| Venlafaxine Hydrochloridevenlafaxine | Venlafaxine hydrochloride 75 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-497 |
| Venlafaxine Hydrochloridevenlafaxine | Venlafaxine hydrochloride 225 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-499 |
| Venlafaxine Hydrochloridevenlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-197 |
| Venlafaxine Hydrochloridevenlafaxine | Venlafaxine hydrochloride 75 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-198 |
| Venlafaxine Hydrochloridevenlafaxine | Venlafaxine hydrochloride 150 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-199 |
| Venlafaxine Hydrochloridevenlafaxine | Venlafaxine hydrochloride 225 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-200 |