Prescription drug · ANDA
venlafaxine hydrochloride NDC 55111-454
Venlafaxine hydrochloride 75 mg/1 · Capsule, Extended release · Oral · Dr.Reddy's Laboratories Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-454-01 | 5511104540155111045401 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-454-01)Marketed from Jun 1, 2011 | |
| 55111-454-05 | 5511104540555111045405 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-454-05)Marketed from Jun 1, 2011 | |
| 55111-454-30 | 5511104543055111045430 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-454-30)Marketed from Jun 1, 2011 | |
| 55111-454-60 | 5511104546055111045460 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-454-60)Marketed from Jun 1, 2011 | |
| 55111-454-78 | 5511104547855111045478 | 10 BLISTER PACK in 1 CARTON (55111-454-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (55111-454-79)Marketed from Jun 1, 2011 | |
| 55111-454-90 | 5511104549055111045490 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-454-90)Marketed from Jun 1, 2011 |
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 — 75 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Dr.Reddy's Laboratories Ltd.NDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078421
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 55111-454_a0b75dbc-2382-70bc-7bd9-c6ef3ee4ed3eSPL ID a0b75dbc-2382-70bc-7bd9-c6ef3ee4ed3eSPL set ID 7027be98-61d6-a986-c9df-60ceef5f7ff0RxCUI 313581, 313583, 313585UNII 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
N455111045401followed by a unit qualifier and the quantityPackage 55111-0454-01. 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)
Venlafaxine hydrochloride extended-release capsules are serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: • Major Depressive Disorder (MDD) • Generalized Anxiety Disorder (GAD) • Social Anxiety Disorder (SAD) • Panic Disorder (PD) 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 establis…
Excerpt only. Read the full label for complete information.
About NDC 55111-454
- What is NDC 55111-454?
- 55111-454 is the product NDC for venlafaxine hydrochloride, Venlafaxine hydrochloride 75 mg/1 capsule, extended release, listed with the FDA by Dr.Reddy's Laboratories Ltd.. 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 Ltd., 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 078421
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 75 mg/1 | Capsule, Extended releaseOral | Dr.Reddys Laboratories Inc | 43598-001 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Dr.Reddys Laboratories Inc | 43598-002 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Dr.Reddys Laboratories Inc | 43598-999 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Capsule, Extended releaseOral | Dr.Reddy's Laboratories Ltd. | 55111-453 |
| venlafaxine hydrochloride | Venlafaxine hydrochloride 150 mg/1 | Capsule, Extended releaseOral | Dr.Reddy's Laboratories Ltd. | 55111-455 |