Prescription drug · ANDA
venlafaxine (Venlafaxine hydrochloride) NDC 71335-1213
Venlafaxine hydrochloride 37.5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1213-1 | 7133512130171335121301 | 30 TABLET in 1 BOTTLE (71335-1213-1)Marketed from Feb 9, 2022 | |
| 71335-1213-2 | 7133512130271335121302 | 60 TABLET in 1 BOTTLE (71335-1213-2)Marketed from Feb 9, 2022 | |
| 71335-1213-3 | 7133512130371335121303 | 90 TABLET in 1 BOTTLE (71335-1213-3)Marketed from Feb 9, 2022 | |
| 71335-1213-4 | 7133512130471335121304 | 10 TABLET in 1 BOTTLE (71335-1213-4)Marketed from Feb 9, 2022 |
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 hydrochloride
- Active ingredients
- Venlafaxine hydrochloride — 37.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090555
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1213_5d4798d1-87f3-44fc-a6fc-ae748478faa6SPL ID 5d4798d1-87f3-44fc-a6fc-ae748478faa6SPL set ID 49e5833b-4693-45b5-9abb-1b369eb4086dRxCUI 313584UNII 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
N471335121301followed by a unit qualifier and the quantityPackage 71335-1213-01. 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 Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should incl…
Excerpt only. Read the full label for complete information.
About NDC 71335-1213
- What is NDC 71335-1213?
- 71335-1213 is the product NDC for venlafaxine (venlafaxine hydrochloride), Venlafaxine hydrochloride 37.5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- venlafaxine (Venlafaxine hydrochloride).
- What is the active ingredient?
- Venlafaxine hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3820 | 70518-3820-00 |
| 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 |
Other NDCs under ANDA 090555
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 |
|---|---|---|---|---|
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1907 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1976 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-4853 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Coupler LLC | 67046-0560 |
| Venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-406 |
| Venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 25 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-404 |
| Venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-405 |
| Venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-407 |
| Venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 100 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-408 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-223 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1385 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1104 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-323 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 75 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2652 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2659 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 50 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-174 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 25 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-172 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-173 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-175 |
| venlafaxinevenlafaxine hydrochloride | Venlafaxine hydrochloride 100 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-176 |