NDC codes

FDA NDC Directory
Product NDC (as listed)42291-868Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42291-0868Add 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
42291-868-1042291086810422910868101000 TABLET in 1 BOTTLE (42291-868-10)Marketed from Nov 6, 2020
42291-868-90422910868904229108689090 TABLET in 1 BOTTLE (42291-868-90)Marketed from Nov 6, 2020

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)
Trazodone Hydrochloride
Generic name (nonproprietary)
trazodone hydrochloride
Active ingredients
Trazodone hydrochloride — 50 mg/1
Dosage form
Tablet
Route
Oral
Labeler
AvKARENDC labeler code 42291
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 071523
Marketing start
Listing expires
Identifiers
Product ID 42291-868_4cc4b32a-0db0-e922-e063-6294a90ab8cdSPL ID 4cc4b32a-0db0-e922-e063-6294a90ab8cdSPL set ID b3723265-7455-c25c-e053-2a95a90a379bRxCUI 856373, 856377UNII 6E8ZO8LRNM
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

N442291086810 followed by a unit qualifier and the quantity

Package 42291-0868-10. 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)

Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone hydrochloride tablets are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-868

What is NDC 42291-868?
42291-868 is the product NDC for Trazodone Hydrochloride, Trazodone hydrochloride 50 mg/1 tablet, listed with the FDA by AvKARE. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Trazodone Hydrochloride.
What is the active ingredient?
Trazodone hydrochloride.
Who is the labeler?
AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Trazodone Hydrochloride?
157 other product NDCs are listed under this name. See all Trazodone 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 Trazodone Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralAmerican Health Packaging60687-96560687-0965-01
Trazodone HydrochlorideTrazodone hydrochloride 50 mg/1TabletOralREMEDYREPACK INC.70518-476070518-4760-0070518-4760-0270518-4760-03+1 more
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralNorthwind Health Company, LLC82868-11682868-0116-90
Trazodone HydrochlorideTrazodone hydrochloride 25 mg/1Tablet, Film coatedOralTRUPHARMA LLC52817-39552817-0395-10
Trazodone HydrochlorideTrazodone hydrochloride 75 mg/1Tablet, Film coatedOralTRUPHARMA LLC52817-39652817-0396-10
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralREMEDYREPACK INC.70518-473770518-4737-0070518-4737-01
Trazodone HydrochlorideTrazodone hydrochloride 50 mg/1TabletOralAmerican Health Packaging60687-95460687-0954-01
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralUnit Dose Solutions, Inc.87441-08087441-0080-01
Trazodone HydrochlorideTrazodone hydrochloride 50 mg/1TabletOralUnit Dose Solutions, Inc.87441-08187441-0081-01
Trazodone HydrochlorideTrazodone hydrochloride 50 mg/1Tablet, Film coatedOralCoupler LLC67046-168467046-1684-03

All 158 Trazodone Hydrochloride NDCs

Other NDCs under ANDA 071523

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

FDA NDC Directory listings under ANDA 071523
ProductStrengthForm · routeLabelerProduct NDC
Trazodone HydrochlorideTrazodone hydrochloride 50 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8371
Trazodone HydrochlorideTrazodone hydrochloride 50 mg/1TabletOralNorthwind Health Company, LLC51655-366
Trazodone HydrochlorideTrazodone hydrochloride 50 mg/1TabletOralREMEDYREPACK INC.70518-2929
Trazodone HydrochlorideTrazodone hydrochloride 50 mg/1TabletOralProficient Rx LP71205-568
Trazodone HydrochlorideTrazodone hydrochloride 50 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-525
Trazodone HydrochlorideTrazodone hydrochloride 50 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-529
Trazodone HydrochlorideTrazodone hydrochloride 50 mg/1TabletOralUnit Dose Solutions, Inc.87441-081

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