What is NDC 64980-594?

64980-594 is the product NDC for Doxepin hydrochloride, Doxepin hydrochloride 10 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 hydrochloride?

173 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Doxepin hydrochloride NDC 64980-594

NDC codes

FDA NDC Directory

Product NDC (as listed)64980-594Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64980-0594Add 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
64980-594-01	6498005940164980059401	100 CAPSULE in 1 BOTTLE (64980-594-01)Marketed from Dec 25, 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 — 10 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 64980
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217975
Marketing start: Dec 25, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 64980-594_2877d1f2-a036-4577-926d-b09828350ea1SPL ID 2877d1f2-a036-4577-926d-b09828350ea1SPL set ID 66c6af99-9909-4b18-a43b-898a1c4a34d7RxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 3U9A0FE9N5UPC 0364980594011, 0364980597012, 0364980595018, 0364980596015, 0364980598019
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

N464980059401 followed by a unit qualifier and the quantity

Package 64980-0594-01. 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 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE 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 symptom…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64980-594

What is NDC 64980-594?: 64980-594 is the product NDC for Doxepin hydrochloride, Doxepin hydrochloride 10 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Doxepin hydrochloride.
What is the active ingredient?: Doxepin hydrochloride.
Who is the labeler?: Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 hydrochloride?: 173 other product NDCs are listed under this name. See all Doxepin 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 Doxepin hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/g	CreamTopical	Sun Pharmaceutical Industries, Inc.	51672-1404	51672-1404-0251672-1404-09
Doxepin Hydrochloride	Doxepin hydrochloride 150 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4733	70518-4733-00
Doxepin hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Coupler LLC	67046-0394	67046-0394-03
Doxepin hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Coupler LLC	67046-0393	67046-0393-03
Doxepin Hydrochloride	Doxepin hydrochloride 10 mg/1	CapsuleOral	Safecor Health, LLC	48433-035	48433-0035-20
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Safecor Health, LLC	48433-036	48433-0036-20
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Safecor Health, LLC	48433-037	48433-0037-20
Doxepin Hydrochloride	Doxepin hydrochloride 100 mg/1	CapsuleOral	Safecor Health, LLC	48433-038	48433-0038-20
doxepin hydrochloride	Doxepin hydrochloride 3 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	51672-4246	51672-4246-02
doxepin hydrochloride	Doxepin hydrochloride 6 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	51672-4247	51672-4247-02

All 174 Doxepin hydrochloride NDCs

Other NDCs under ANDA 217975

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

FDA NDC Directory listings under ANDA 217975
Product	Strength	Form · route	Labeler	Product NDC
Doxepin hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	64980-595
Doxepin hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	64980-596
Doxepin hydrochloride	Doxepin hydrochloride 75 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	64980-597
Doxepin hydrochloride	Doxepin hydrochloride 100 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	64980-598