Doxepin Hydrochloride NDC 0378-8117

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8117Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8117Add 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
0378-8117-45	00378811745	1 TUBE in 1 CARTON (0378-8117-45) / 45 g in 1 TUBEMarketed from Jan 4, 2019

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 — 50 mg/g
Dosage form: Cream
Route: Topical
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020126
Marketing start: Jan 4, 2019
Listing expires: Dec 31, 2026
Identifiers: Product ID 0378-8117_b4771ea7-c19b-4182-bb23-c1473ab583faSPL ID b4771ea7-c19b-4182-bb23-c1473ab583faSPL set ID b4771ea7-c19b-4182-bb23-c1473ab583faRxCUI 1000091UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378811745 followed by a unit qualifier and the quantity

Package 00378-8117-45. 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 May 24, 2017.

Indications (excerpt from the label)

INDICATIONS AND USAGE Doxepin Hydrochloride Cream, 5% is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION .)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)