zonalon

Generic: doxepin hydrochloride

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zonalon
Generic Name doxepin hydrochloride
Labeler mylan pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

doxepin hydrochloride 50 mg/g

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8123
Product ID 0378-8123_d08db934-a9ce-4b1a-9ca1-5c6705b227a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020126
Listing Expiration 2026-12-31
Marketing Start 2018-11-14

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03788123
Hyphenated Format 0378-8123

Supplemental Identifiers

RxCUI
1000091 1000095
UNII
3U9A0FE9N5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zonalon (source: ndc)
Generic Name doxepin hydrochloride (source: ndc)
Application Number NDA020126 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0378-8123-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0378-8123-45) / 45 g in 1 TUBE
source: ndc

Packages (2)

0378-8123-30 1 TUBE in 1 CARTON (0378-8123-30) / 30 g in 1 TUBE 0378-8123-45 1 TUBE in 1 CARTON (0378-8123-45) / 45 g in 1 TUBE

Ingredients (1)

doxepin hydrochloride (50 mg/g)

Linked Drug Pages (1)

Zonalon ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d08db934-a9ce-4b1a-9ca1-5c6705b227a1", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["1000091", "1000095"], "spl_set_id": ["5f302247-525e-4acc-852b-00eb1d79af4b"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0378-8123-30)  / 30 g in 1 TUBE", "package_ndc": "0378-8123-30", "marketing_start_date": "20181126"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0378-8123-45)  / 45 g in 1 TUBE", "package_ndc": "0378-8123-45", "marketing_start_date": "20181114"}], "brand_name": "Zonalon", "product_id": "0378-8123_d08db934-a9ce-4b1a-9ca1-5c6705b227a1", "dosage_form": "CREAM", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "0378-8123", "generic_name": "doxepin hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zonalon", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "50 mg/g"}], "application_number": "NDA020126", "marketing_category": "NDA", "marketing_start_date": "20181114", "listing_expiration_date": "20261231"}