Prescription drug · ANDA
Venlafaxine HCL ER (Venlafaxine hcl) NDC 80425-0194
Venlafaxine hydrochloride 150 mg/1 · Capsule, Extended release · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0194-2 | 8042501940280425019402 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0194-2)Marketed from Feb 25, 2024 |
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 HCL ERSuffix: ER
- Generic name (nonproprietary)
- venlafaxine hcl
- Active ingredients
- Venlafaxine hydrochloride — 150 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212277
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0194_2a99c981-daf5-71e5-e063-6294a90a5c1dSPL ID 2a99c981-daf5-71e5-e063-6294a90a5c1dSPL set ID d8e00b3d-29de-1de5-e053-2995a90acb51RxCUI 313581UNII 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
N480425019402followed by a unit qualifier and the quantityPackage 80425-0194-02. 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)
1. 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. Efficac…
Excerpt only. Read the full label for complete information.
About NDC 80425-0194
- What is NDC 80425-0194?
- 80425-0194 is the product NDC for Venlafaxine HCL ER (venlafaxine hcl), Venlafaxine hydrochloride 150 mg/1 capsule, extended release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Venlafaxine HCL ER (Venlafaxine HCL).
- What is the active ingredient?
- Venlafaxine hydrochloride.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 HCL ER?
- 2 other product NDCs are listed under this name. See all Venlafaxine HCL ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Venlafaxine HCL ER 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 HCL ER | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Direct_Rx | 72189-414 | 72189-0414-3072189-0414-6072189-0414-90 |
| Venlafaxine HCL ER | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Direct_Rx | 72189-363 | 72189-0363-3072189-0363-60 |
Other NDCs under ANDA 212277
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 | Camber Pharmaceuticals, Inc. | 31722-002 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-003 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-004 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-5890 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-5942 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | AvPAK | 50268-873 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | AvPAK | 50268-874 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | AvPAK | 50268-875 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2393 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-7891 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-8068 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-8072 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4280 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 71205-812 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-1812 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-1868 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-9605 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Annora Pharma Private Limited | 71785-1006 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Annora Pharma Private Limited | 71785-1007 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Annora Pharma Private Limited | 71785-1008 |
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