Prescription drug · ANDA
Venlafaxine HCL ER NDC 72189-363
Venlafaxine hydrochloride 37.5 mg/1 · Capsule, Extended release · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-363-30 | 7218903633072189036330 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-363-30)Marketed from Aug 26, 2022 | |
| 72189-363-60 | 7218903636072189036360 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-363-60)Marketed from Jun 22, 2022 |
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 HCL ER
- Generic name (nonproprietary)
- venlafaxine hcl er
- Active ingredients
- Venlafaxine hydrochloride — 37.5 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200834
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 72189-363_2c4c85cc-c2bb-ac98-e063-6294a90a973cSPL ID 2c4c85cc-c2bb-ac98-e063-6294a90a973cSPL set ID e20b7d9e-f755-4325-e053-2995a90ac45dRxCUI 313583UNII 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
N472189036330followed by a unit qualifier and the quantityPackage 72189-0363-30. 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 .
Indications (excerpt from the label)
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 was established in four…
Excerpt only. Read the full label for complete information.
About NDC 72189-363
- What is NDC 72189-363?
- 72189-363 is the product NDC for Venlafaxine HCL ER, Venlafaxine hydrochloride 37.5 mg/1 capsule, extended release, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Venlafaxine HCL ER.
- What is the active ingredient?
- Venlafaxine hydrochloride.
- Who is the labeler?
- Direct_Rx, NDC labeler code 72189. 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 ERvenlafaxine hcl | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0194 | 80425-0194-02 |
Other NDCs under ANDA 200834
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 HCL ER | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Direct_Rx | 72189-414 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Major Pharmaceuticals | 0904-7487 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Major Pharmaceuticals | 0904-7488 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Major Pharmaceuticals | 0904-7489 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | QPharma, Inc. | 42708-194 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-2180 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-2281 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-2519 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-6517 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-6599 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-6896 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-7940 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-7941 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-7942 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Northwind Health Company, LLC | 51655-849 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Cardinal Health 107, LLC | 55154-0197 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-836 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 65862-527 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 65862-528 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 75 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-0390 |
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