What is NDC 54838-512?

54838-512 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 10 mg/mL solution, listed with the FDA by Lannett Company, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Lannett Company, LLC, NDC labeler code 54838. 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 54838-512

NDC codes

FDA NDC Directory

Product NDC (as listed)54838-512Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54838-0512Add 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
54838-512-40	5483805124054838051240	120 mL in 1 BOTTLE, PLASTIC (54838-512-40)Marketed from Dec 29, 1998

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/mL
Dosage form: Solution
Route: Oral
Labeler: Lannett Company, LLCNDC labeler code 54838
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074721
Marketing start: Dec 29, 1998
Listing expires: Dec 31, 2027
Identifiers: Product ID 54838-512_dee418b7-9198-4c68-b720-16433375a1f5SPL ID dee418b7-9198-4c68-b720-16433375a1f5
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

N454838051240 followed by a unit qualifier and the quantity

Package 54838-0512-40. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 54838-512

What is NDC 54838-512?: 54838-512 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 10 mg/mL solution, listed with the FDA by Lannett Company, 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?: Lannett Company, LLC, NDC labeler code 54838. 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