Prescription drug · ANDA
Nefazodone Hydrochloride NDC 63629-7046
Nefazodone hydrochloride 150 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-7046-1 | 63629704601 | 30 TABLET in 1 BOTTLE (63629-7046-1)Marketed from Feb 8, 2022 | |
| 63629-7046-2 | 63629704602 | 120 TABLET in 1 BOTTLE (63629-7046-2)Marketed from Oct 18, 2016 | |
| 63629-7046-3 | 63629704603 | 28 TABLET in 1 BOTTLE (63629-7046-3)Marketed from Feb 8, 2022 | |
| 63629-7046-4 | 63629704604 | 60 TABLET in 1 BOTTLE (63629-7046-4)Marketed from Feb 8, 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)
- Nefazodone Hydrochloride
- Generic name (nonproprietary)
- nefazodone hydrochloride
- Active ingredients
- Nefazodone hydrochloride — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076037
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-7046_8962e4a7-1e27-4a03-ab51-34fc4f9c6847SPL ID 8962e4a7-1e27-4a03-ab51-34fc4f9c6847SPL set ID 0bd4c34a-4f43-4c84-8b98-1d074cba97d5RxCUI 1098666UNII 27X63J94GR
- Pharmacologic class
- Serotonin 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
N463629704601followed by a unit qualifier and the quantityPackage 63629-7046-01. 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 Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS ). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARM…
Excerpt only. Read the full label for complete information.
About NDC 63629-7046
- What is NDC 63629-7046?
- 63629-7046 is the product NDC for Nefazodone Hydrochloride, Nefazodone hydrochloride 150 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?
- Nefazodone Hydrochloride.
- What is the active ingredient?
- Nefazodone hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nefazodone Hydrochloride?
- 5 other product NDCs are listed under this name. See all Nefazodone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nefazodone 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) |
|---|---|---|---|---|---|
| Nefazodone Hydrochloride | Nefazodone hydrochloride 100 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-1024 | 00093-1024-06 |
| Nefazodone Hydrochloride | Nefazodone hydrochloride 200 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-1025 | 00093-1025-06 |
| Nefazodone Hydrochloride | Nefazodone hydrochloride 250 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-1026 | 00093-1026-06 |
| Nefazodone Hydrochloride | Nefazodone hydrochloride 150 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-7113 | 00093-7113-06 |
| Nefazodone Hydrochloride | Nefazodone hydrochloride 50 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-7178 | 00093-7178-01 |
Other NDCs under ANDA 076037
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 |
|---|---|---|---|---|
| Nefazodone Hydrochloride | Nefazodone hydrochloride 100 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-1024 |
| Nefazodone Hydrochloride | Nefazodone hydrochloride 200 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-1025 |
| Nefazodone Hydrochloride | Nefazodone hydrochloride 250 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-1026 |
| Nefazodone Hydrochloride | Nefazodone hydrochloride 150 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-7113 |
| Nefazodone Hydrochloride | Nefazodone hydrochloride 50 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-7178 |