NDC codes

FDA NDC Directory
Product NDC (as listed)50111-561Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50111-0561Add 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
50111-561-015011105610150111056101100 TABLET in 1 BOTTLE (50111-561-01)Marketed from Dec 8, 2020
50111-561-025011105610250111056102500 TABLET in 1 BOTTLE (50111-561-02)Marketed from Dec 8, 2020
50111-561-0350111056103501110561031000 TABLET in 1 BOTTLE (50111-561-03)Marketed from Oct 8, 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 — 100 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Teva Pharmaceuticals USA, Inc.NDC labeler code 50111
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 071524
Marketing start
Listing expires
Identifiers
Product ID 50111-561_3313a8d0-eb39-47a4-b476-0973aad30e02SPL ID 3313a8d0-eb39-47a4-b476-0973aad30e02SPL set ID 4006d439-e2de-4590-82e9-fc9d56e3ec1bRxCUI 856364, 856373, 856377UNII 6E8ZO8LRNMUPC 0350111450011
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

N450111056101 followed by a unit qualifier and the quantity

Package 50111-0561-01. 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)

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 50111-561

What is NDC 50111-561?
50111-561 is the product NDC for Trazodone Hydrochloride, Trazodone hydrochloride 100 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 3 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?
Teva Pharmaceuticals USA, Inc., NDC labeler code 50111. 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 071524

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

FDA NDC Directory listings under ANDA 071524
ProductStrengthForm · routeLabelerProduct NDC
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8386
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralAvKARE42291-869
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralNorthwind Health Company, LLC51655-986
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralREMEDYREPACK INC.70518-2973
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralProficient Rx LP71205-574
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-530
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-537
Trazodone HydrochlorideTrazodone hydrochloride 100 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-424

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