What is NDC 72189-355?

72189-355 is the product NDC for Doxepin HCL, Doxepin hydrochloride 10 mg/1 capsule, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Doxepin HCL?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Doxepin HCL NDC 72189-355 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-355Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0355Add 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
72189-355-30	7218903553072189035530	30 CAPSULE in 1 BOTTLE (72189-355-30)Marketed from May 10, 2022

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): Doxepin HCL
Generic name (nonproprietary): doxepin hcl
Active ingredients: Doxepin hydrochloride — 10 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213063
Marketing start: May 10, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 72189-355_2c4c85cc-c2b7-ac98-e063-6294a90a973cSPL ID 2c4c85cc-c2b7-ac98-e063-6294a90a973cSPL set ID dea965fe-6b54-bbf0-e053-2a95a90a1003RxCUI 1000048UNII 3U9A0FE9N5
Pharmacologic class: Tricyclic Antidepressant

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

N472189035530 followed by a unit qualifier and the quantity

Package 72189-0355-30. 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 Jan 22, 2025.

Indications (excerpt from the label)

Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-355

What is NDC 72189-355?: 72189-355 is the product NDC for Doxepin HCL, Doxepin hydrochloride 10 mg/1 capsule, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Doxepin HCL.
What is the active ingredient?: Doxepin hydrochloride.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Doxepin HCL?: 4 other product NDCs are listed under this name. See all Doxepin HCL 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 Doxepin HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Doxepin HCL	Doxepin hydrochloride 10 mg/1	CapsuleOral	Direct_Rx	72189-633	72189-0633-30
Doxepin HCL	Doxepin hydrochloride 10 mg/1	CapsuleOral	Direct_rx	72189-590	72189-0590-30
Doxepin HCL	Doxepin hydrochloride 10 mg/1	CapsuleOral	Direct_rx	72189-574	72189-0574-30
Doxepin HCL	Doxepin hydrochloride 25 mg/1	CapsuleOral	Direct_Rx	72189-533	72189-0533-30

Other NDCs under ANDA 213063

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

FDA NDC Directory listings under ANDA 213063
Product	Strength	Form · route	Labeler	Product NDC
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	A-S Medication Solutions	50090-5286
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	direct rx	72189-161
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0316