Prescription drug · ANDA
Venlafaxine hydrochloride NDC 55111-547
Venlafaxine hydrochloride 50 mg/1 · Tablet · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-547-01 | 5511105470155111054701 | 100 TABLET in 1 BOTTLE (55111-547-01)Marketed from Jun 16, 2008 | |
| 55111-547-05 | 5511105470555111054705 | 500 TABLET in 1 BOTTLE (55111-547-05)Marketed from Jun 16, 2008 | |
| 55111-547-30 | 5511105473055111054730 | 30 TABLET in 1 BOTTLE (55111-547-30)Marketed from Jun 16, 2008 | |
| 55111-547-60 | 5511105476055111054760 | 60 TABLET in 1 BOTTLE (55111-547-60)Marketed from Jun 16, 2008 | |
| 55111-547-79 | 5511105477955111054779 | 1 BLISTER PACK in 1 CARTON (55111-547-79) / 10 TABLET in 1 BLISTER PACKMarketed from Jun 16, 2008 | |
| 55111-547-90 | 5511105479055111054790 | 90 TABLET in 1 BOTTLE (55111-547-90)Marketed from Jun 16, 2008 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078301
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 55111-547_20a19933-a7c1-3739-c472-272204375d1eSPL ID 20a19933-a7c1-3739-c472-272204375d1eSPL set ID 106d0d7b-925b-74e7-83cb-562144ce1f92RxCUI 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
N455111054701followed by a unit qualifier and the quantityPackage 55111-0547-01. 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 are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride 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 …
Excerpt only. Read the full label for complete information.
About NDC 55111-547
- What is NDC 55111-547?
- 55111-547 is the product NDC for Venlafaxine hydrochloride, Venlafaxine hydrochloride 50 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 6 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?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 078301
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 25 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-545 |
| Venlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-546 |
| Venlafaxine hydrochloride | Venlafaxine hydrochloride 75 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-548 |
| Venlafaxine hydrochloride | Venlafaxine hydrochloride 100 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-549 |