Prescription drug · ANDA
Venlafaxine Hydrochloride NDC 42291-898
Venlafaxine hydrochloride 75 mg/1 · Capsule, Extended release · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-898-30 | 4229108983042291089830 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-898-30)Marketed from Jun 21, 2021 | |
| 42291-898-50 | 4229108985042291089850 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-898-50)Marketed from Jun 21, 2021 | |
| 42291-898-90 | 4229108989042291089890 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-898-90)Marketed from Jul 10, 2013 |
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 — 75 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076565
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 42291-898_488438c1-31da-f4c3-e063-6394a90a9a38SPL ID 488438c1-31da-f4c3-e063-6394a90a9a38SPL set ID 7f224c88-9425-9ef0-01bc-dcf3bdafbd89RxCUI 313581, 313583, 313585UNII 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
N442291089830followed by a unit qualifier and the quantityPackage 42291-0898-30. 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)
INDICATIONS AND USAGE 1.1 Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. 1.2 Generalized Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. 1.3 Social Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy w…
Excerpt only. Read the full label for complete information.
About NDC 42291-898
- What is NDC 42291-898?
- 42291-898 is the product NDC for Venlafaxine Hydrochloride, Venlafaxine hydrochloride 75 mg/1 capsule, extended release, listed with the FDA by AvKARE. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Venlafaxine Hydrochloride.
- What is the active ingredient?
- Venlafaxine hydrochloride.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. 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 076565
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 75 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 63187-177 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | QPharma, Inc. | 42708-054 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-897 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-899 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 63187-420 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-7384 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-7385 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-6214 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-7386 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 63187-481 |