Prescription drug · ANDA
Venlafaxine NDC 71209-029
Venlafaxine hydrochloride 100 mg/1 · Tablet · Oral · Cadila Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71209-029-05 | 71209002905 | 100 TABLET in 1 BOTTLE (71209-029-05)Marketed from Dec 3, 2018 |
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
- Generic name (nonproprietary)
- venlafaxine
- Active ingredients
- Venlafaxine hydrochloride — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cadila Pharmaceuticals LimitedNDC labeler code 71209
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206250
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71209-029_f6bcbdd6-db09-4aeb-8eb0-6eadb8ebdebaSPL ID f6bcbdd6-db09-4aeb-8eb0-6eadb8ebdebaSPL set ID 2ed61dcf-42e3-47cf-a607-459eef5fea98RxCUI 313580, 313582, 313584, 313586, 314277UNII 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
N471209002905followed by a unit qualifier and the quantityPackage 71209-0029-05. 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 & USAGE Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets 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 include at least…
Excerpt only. Read the full label for complete information.
About NDC 71209-029
- What is NDC 71209-029?
- 71209-029 is the product NDC for Venlafaxine, Venlafaxine hydrochloride 100 mg/1 tablet, listed with the FDA by Cadila Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Venlafaxine.
- What is the active ingredient?
- Venlafaxine hydrochloride.
- Who is the labeler?
- Cadila Pharmaceuticals Limited, NDC labeler code 71209. 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?
- 116 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) |
|---|---|---|---|---|---|
| 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 |
| Venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | Tablet, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-221 | 27241-0221-3027241-0221-90 |
Other NDCs under ANDA 206250
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 | Venlafaxine hydrochloride 25 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-025 |
| Venlafaxine | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-026 |
| Venlafaxine | Venlafaxine hydrochloride 50 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-027 |
| Venlafaxine | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-028 |