Prescription drug · ANDA
venlafaxine hydrochloride, extended release NDC 42799-963
Venlafaxine hydrochloride 225 mg/1 · Tablet · Oral · Edenbridge Pharmaceuticals LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42799-963-01 | 42799096301 | 30 TABLET in 1 BOTTLE (42799-963-01)Marketed from Mar 15, 2023 | |
| 42799-963-02 | 42799096302 | 90 TABLET in 1 BOTTLE (42799-963-02)Marketed from Mar 15, 2023 |
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, extended release
- Generic name (nonproprietary)
- venlafaxine hydrochloride, extended release
- Active ingredients
- Venlafaxine hydrochloride — 225 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Edenbridge Pharmaceuticals LLC.NDC labeler code 42799
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209193
- Marketing start
- Marketing end
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 42799-963_157aa0f9-6266-4758-9d6b-5fc77cdc03a4SPL ID 157aa0f9-6266-4758-9d6b-5fc77cdc03a4SPL set ID 38431a76-6185-4c17-994f-8278b6cd7510RxCUI 808744, 808748UNII 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
N442799096301followed by a unit qualifier and the quantityPackage 42799-0963-01. 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 Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1.1 ) Social Anxiety Disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder Venlafaxine Hydrochloride Extended-Release Tablets are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [see Clinical Studies ( 14.1 )] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, repre…
Excerpt only. Read the full label for complete information.
About NDC 42799-963
- What is NDC 42799-963?
- 42799-963 is the product NDC for venlafaxine hydrochloride, extended release, Venlafaxine hydrochloride 225 mg/1 tablet, listed with the FDA by Edenbridge Pharmaceuticals LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- venlafaxine hydrochloride, extended release.
- What is the active ingredient?
- Venlafaxine hydrochloride.
- Who is the labeler?
- Edenbridge Pharmaceuticals LLC., NDC labeler code 42799. 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, extended release?
- 1 other product NDC are listed under this name. See all venlafaxine hydrochloride, extended release 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, extended release 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, extended release | Venlafaxine hydrochloride 150 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-962 | 42799-0962-0142799-0962-02 |
Other NDCs under ANDA 209193
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 225 mg/1 | TabletOral | Chartwell RX, LLC | 62135-531 |
| venlafaxine hydrochloride, extended release | Venlafaxine hydrochloride 150 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-962 |