What is NDC 43353-329?

43353-329 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 10 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 43353-329

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-329Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0329Add 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
43353-329-09	4335303290943353032909	9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-329-09)Marketed from May 21, 2017

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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070791
Marketing start: May 13, 1986
Listing expires: Dec 31, 2026
Identifiers: Product ID 43353-329_a3797445-680f-449e-8ffd-522445906bdbSPL ID a3797445-680f-449e-8ffd-522445906bdbSPL set ID 10d9eba6-30d1-448a-8d92-a1a02df03303RxCUI 1000048, 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

N443353032909 followed by a unit qualifier and the quantity

Package 43353-0329-09. 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 Sep 5, 2017. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Doxepin Hydrochloride Capsules, USP are 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 capsules include anxiety, tension, depression, som…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43353-329

What is NDC 43353-329?: 43353-329 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 10 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 070791

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

FDA NDC Directory listings under ANDA 070791
Product	Strength	Form · route	Labeler	Product NDC
Doxepin Hydrochloride	Doxepin hydrochloride 10 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-1049
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-3125
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-4250
Doxepin Hydrochloride	Doxepin hydrochloride 75 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-5375
Doxepin Hydrochloride	Doxepin hydrochloride 100 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-6410
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	43353-331
Doxepin Hydrochloride	Doxepin hydrochloride 10 mg/1	CapsuleOral	Safecor Health, LLC	48433-035
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Safecor Health, LLC	48433-036
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Safecor Health, LLC	48433-037
Doxepin Hydrochloride	Doxepin hydrochloride 100 mg/1	CapsuleOral	Safecor Health, LLC	48433-038
Doxepin Hydrochloride	Doxepin hydrochloride 10 mg/1	CapsuleOral	Mylan Institutional Inc.	51079-436
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Mylan Institutional Inc.	51079-437
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Mylan Institutional Inc.	51079-438
Doxepin Hydrochloride	Doxepin hydrochloride 100 mg/1	CapsuleOral	Mylan Institutional Inc.	51079-651
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	55289-370
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-5033
Doxepin Hydrochloride	Doxepin hydrochloride 10 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-072