NDC codes

FDA NDC Directory
Product NDC (as listed)63629-7046Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-7046Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
63629-7046-16362970460130 TABLET in 1 BOTTLE (63629-7046-1)Marketed from Feb 8, 2022
63629-7046-263629704602120 TABLET in 1 BOTTLE (63629-7046-2)Marketed from Oct 18, 2016
63629-7046-36362970460328 TABLET in 1 BOTTLE (63629-7046-3)Marketed from Feb 8, 2022
63629-7046-46362970460460 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

N463629704601 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nefazodone Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nefazodone HydrochlorideNefazodone hydrochloride 100 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-102400093-1024-06
Nefazodone HydrochlorideNefazodone hydrochloride 200 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-102500093-1025-06
Nefazodone HydrochlorideNefazodone hydrochloride 250 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-102600093-1026-06
Nefazodone HydrochlorideNefazodone hydrochloride 150 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-711300093-7113-06
Nefazodone HydrochlorideNefazodone hydrochloride 50 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-717800093-7178-01

Other NDCs under ANDA 076037

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076037
ProductStrengthForm · routeLabelerProduct NDC
Nefazodone HydrochlorideNefazodone hydrochloride 100 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-1024
Nefazodone HydrochlorideNefazodone hydrochloride 200 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-1025
Nefazodone HydrochlorideNefazodone hydrochloride 250 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-1026
Nefazodone HydrochlorideNefazodone hydrochloride 150 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-7113
Nefazodone HydrochlorideNefazodone hydrochloride 50 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-7178

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