Doxepin Hydrochloride NDC 24658-795

NDC codes

FDA NDC Directory

Product NDC (as listed)24658-795Labeler and product segments. Claims need a package NDC.

Product NDC at billing width24658-0795Add 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
24658-795-01	24658079501	100 CAPSULE in 1 BOTTLE (24658-795-01)Marketed from Mar 14, 2023
24658-795-10	24658079510	1000 CAPSULE in 1 BOTTLE (24658-795-10)Marketed from Mar 14, 2023

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 Hydrochloride
Generic name (nonproprietary): doxepin hydrochloride
Active ingredients: Doxepin hydrochloride — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210675
Marketing start: Mar 14, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 24658-795_14002bad-2577-436d-91ca-ec1b80ab0c97SPL ID 14002bad-2577-436d-91ca-ec1b80ab0c97SPL set ID 14002bad-2577-436d-91ca-ec1b80ab0c97RxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 3U9A0FE9N5UPC 0324658793016, 0324658797106, 0324658796017, 0324658794013, 0324658795010
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

N424658079501 followed by a unit qualifier and the quantity

Package 24658-0795-01. 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 Mar 17, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Doxepin hydrochloride capsule is recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. 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 include anxiety, tension, depression, somatic symptoms an…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210675

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

FDA NDC Directory listings under ANDA 210675
Product	Strength	Form · route	Labeler	Product NDC
Doxepin Hydrochloride	Doxepin hydrochloride 10 mg/1	CapsuleOral	Epic Pharma, LLC	42806-529
Doxepin Hydrochloride	Doxepin hydrochloride 75 mg/1	CapsuleOral	Epic Pharma, LLC	42806-532
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Epic Pharma, LLC	42806-530
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Epic Pharma, LLC	42806-531
Doxepin Hydrochloride	Doxepin hydrochloride 100 mg/1	CapsuleOral	Epic Pharma, LLC	42806-533
Doxepin Hydrochloride	Doxepin hydrochloride 10 mg/1	CapsuleOral	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-793
Doxepin Hydrochloride	Doxepin hydrochloride 100 mg/1	CapsuleOral	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-797
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-794
Doxepin Hydrochloride	Doxepin hydrochloride 75 mg/1	CapsuleOral	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-796