What is NDC 45865-167?

45865-167 is the product NDC for Trazodone Hydrochloride, Trazodone hydrochloride 50 mg/1 tablet, listed with the FDA by Medsource Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.

Medsource Pharmaceuticals, NDC labeler code 45865. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Trazodone Hydrochloride NDC 45865-167

NDC codes

FDA NDC Directory

Product NDC (as listed)45865-167Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45865-0167Add 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 NDC	11-digit (billing)	Package	Copy
45865-167-30	4586501673045865016730	30 TABLET in 1 BOTTLE (45865-167-30)Marketed from Sep 8, 2021
45865-167-60	4586501676045865016760	60 TABLET in 1 BOTTLE (45865-167-60)Marketed from Apr 8, 2021

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: Medsource PharmaceuticalsNDC labeler code 45865
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205253
Marketing start: Dec 11, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 45865-167_12f16727-8822-5b6c-e063-6394a90a02a6SPL ID 12f16727-8822-5b6c-e063-6394a90a02a6SPL set ID 12f1737b-c021-d0f2-e063-6294a90a6f29RxCUI 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

N445865016730 followed by a unit qualifier and the quantity

Package 45865-0167-30. 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 Mar 5, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45865-167

What is NDC 45865-167?: 45865-167 is the product NDC for Trazodone Hydrochloride, Trazodone hydrochloride 50 mg/1 tablet, listed with the FDA by Medsource Pharmaceuticals. 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?: Medsource Pharmaceuticals, NDC labeler code 45865. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Trazodone Hydrochloride	Trazodone hydrochloride 100 mg/1	TabletOral	American Health Packaging	60687-965	60687-0965-01
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-4760	70518-4760-0070518-4760-0270518-4760-03+1 more
Trazodone Hydrochloride	Trazodone hydrochloride 100 mg/1	TabletOral	Northwind Health Company, LLC	82868-116	82868-0116-90
Trazodone Hydrochloride	Trazodone hydrochloride 25 mg/1	Tablet, Film coatedOral	TRUPHARMA LLC	52817-395	52817-0395-10
Trazodone Hydrochloride	Trazodone hydrochloride 75 mg/1	Tablet, Film coatedOral	TRUPHARMA LLC	52817-396	52817-0396-10
Trazodone Hydrochloride	Trazodone hydrochloride 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-4737	70518-4737-0070518-4737-01
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	American Health Packaging	60687-954	60687-0954-01
Trazodone Hydrochloride	Trazodone hydrochloride 100 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-080	87441-0080-01
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-081	87441-0081-01
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1684	67046-1684-03

All 158 Trazodone Hydrochloride NDCs

Other NDCs under ANDA 205253

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

FDA NDC Directory listings under ANDA 205253
Product	Strength	Form · route	Labeler	Product NDC
Trazodone Hydrochloride	Trazodone hydrochloride 100 mg/1	TabletOral	American Health Packaging	60687-454
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	A-S Medication Solutions	50090-7943
Trazodone Hydrochloride	Trazodone hydrochloride 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-0730
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	A-S Medication Solutions	50090-7944
Trazodone Hydrochloride	Trazodone hydrochloride 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-0742
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4410
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-154
Trazodone HCl	Trazodone hydrochloride 50 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0176
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	Proficient Rx LP	71205-551
Trazodone Hydrochloride	Trazodone hydrochloride 100 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-168
Trazodone Hydrochloride	Trazodone hydrochloride 100 mg/1	TabletOral	Asclemed USA, Inc.	76420-648
Trazodone Hydrochloride	Trazodone hydrochloride 150 mg/1	TabletOral	Major Pharmaceuticals	0904-7212
Trazodone Hydrochloride	Trazodone hydrochloride 100 mg/1	TabletOral	Cardinal Health 107, LLC	55154-8085
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	Asclemed USA, Inc.	76420-672
Trazodone Hydrochloride	Trazodone hydrochloride 100 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1939
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	Cardinal Health 107, LLC	55154-8087
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7118
Trazodone Hydrochloride	Trazodone hydrochloride 150 mg/1	TabletOral	REMEDYREPACK INC.	70518-2180
Trazodone Hydrochloride	Trazodone hydrochloride 100 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7137
Trazodone Hydrochloride	Trazodone hydrochloride 50 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1938

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