What is NDC 0378-8123?

0378-8123 is the product NDC for Zonalon (doxepin hydrochloride), Doxepin hydrochloride 50 mg/g cream, 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?

Zonalon (Doxepin hydrochloride).

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 Zonalon?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zonalon NDC 0378-8123 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8123Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8123Add 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
0378-8123-30	0037881233000378812330	1 TUBE in 1 CARTON (0378-8123-30) / 30 g in 1 TUBEMarketed from Nov 26, 2018
0378-8123-45	0037881234500378812345	1 TUBE in 1 CARTON (0378-8123-45) / 45 g in 1 TUBEMarketed from Nov 14, 2018

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): Zonalon
Generic name (nonproprietary): doxepin hydrochloride
Active ingredients: Doxepin hydrochloride — 50 mg/g
Dosage form: Cream
Route: Topical
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020126
Marketing start: Nov 14, 2018
Listing expires: Dec 31, 2027
Identifiers: Product ID 0378-8123_d08db934-a9ce-4b1a-9ca1-5c6705b227a1SPL ID d08db934-a9ce-4b1a-9ca1-5c6705b227a1SPL set ID 5f302247-525e-4acc-852b-00eb1d79af4bRxCUI 1000091, 1000095UNII 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

N400378812330 followed by a unit qualifier and the quantity

Package 00378-8123-30. 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 Jun 14, 2017.

Indications (excerpt from the label)

INDICATIONS AND USAGE Zonalon ® Cream 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)

About NDC 0378-8123

What is NDC 0378-8123?: 0378-8123 is the product NDC for Zonalon (doxepin hydrochloride), Doxepin hydrochloride 50 mg/g cream, 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?: Zonalon (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 Zonalon?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 020126

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

FDA NDC Directory listings under NDA 020126
Product	Strength	Form · route	Labeler	Product NDC
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/g	CreamTopical	Mylan Pharmaceuticals Inc.	0378-8117
Prudoxindoxepin hydrochloride	Doxepin hydrochloride 50 mg/g	CreamTopical	Mylan Pharmaceuticals Inc.	0378-8130

Zonalon (Doxepin hydrochloride) NDC 0378-8123