Doxepin Hydrochloride NDC 80425-0316

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0316Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0316Add 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
80425-0316-1	80425031601	30 CAPSULE in 1 BOTTLE (80425-0316-1)Marketed from Apr 10, 2023
80425-0316-2	80425031602	60 CAPSULE in 1 BOTTLE (80425-0316-2)Marketed from Apr 10, 2023
80425-0316-3	80425031603	90 CAPSULE in 1 BOTTLE (80425-0316-3)Marketed from Apr 10, 2023

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): Doxepin Hydrochloride
Generic name (nonproprietary): doxepin hydrochloride
Active ingredients: Doxepin hydrochloride — 25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213063
Marketing start: Apr 10, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 80425-0316_2a9bf621-afbf-7627-e063-6294a90a77a9SPL ID 2a9bf621-afbf-7627-e063-6294a90a77a9SPL set ID f900bac4-02f2-6bf3-e053-6394a90a2161RxCUI 1000070UNII 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

N480425031601 followed by a unit qualifier and the quantity

Package 80425-0316-01. 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 Dec 31, 2024. This label includes a boxed warning.

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)

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 HCL	Doxepin hydrochloride 10 mg/1	CapsuleOral	Direct_Rx	72189-355
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