What is NDC 0378-1049?

0378-1049 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 10 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-1049

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-1049Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-1049Add 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
0378-1049-01	0037810490100378104901	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-01)Marketed from May 13, 1986
0378-1049-10	0037810491000378104910	1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-10)Marketed from May 13, 1986

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070791
Marketing start: May 13, 1986
Listing expires: Dec 31, 2027
Identifiers: Product ID 0378-1049_335104fb-31eb-4460-b3ab-19869176b320SPL ID 335104fb-31eb-4460-b3ab-19869176b320SPL set ID 1533343b-f1ed-4c3a-bb36-23a748452b05RxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 3U9A0FE9N5UPC 0303785375012, 0303786410019, 0303784250013, 0303781049016, 0303783125015
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

N400378104901 followed by a unit qualifier and the quantity

Package 00378-1049-01. 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 Oct 15, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride capsules are a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-1049

What is NDC 0378-1049?: 0378-1049 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 10 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 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 10 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	43353-329
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