doxepin hydrochloride

Generic: doxepin hydrochloride

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

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler mylan pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 25 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3125
Product ID 0378-3125_335104fb-31eb-4460-b3ab-19869176b320
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070791
Listing Expiration 2026-12-31
Marketing Start 1986-05-13

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03783125
Hyphenated Format 0378-3125

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0303785375012 0303786410019 0303784250013 0303781049016 0303783125015
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 doxepin hydrochloride (source: ndc)
Generic Name doxepin hydrochloride (source: ndc)
Application Number ANDA070791 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-01)
  • 1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-10)
source: ndc

Packages (2)

0378-3125-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-01) 0378-3125-10 1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-10)

Ingredients (1)

doxepin hydrochloride (25 mg/1)

Linked Drug Pages (1)

Doxepin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "335104fb-31eb-4460-b3ab-19869176b320", "openfda": {"upc": ["0303785375012", "0303786410019", "0303784250013", "0303781049016", "0303783125015"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["1533343b-f1ed-4c3a-bb36-23a748452b05"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-01)", "package_ndc": "0378-3125-01", "marketing_start_date": "19860513"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-10)", "package_ndc": "0378-3125-10", "marketing_start_date": "19860513"}], "brand_name": "Doxepin Hydrochloride", "product_id": "0378-3125_335104fb-31eb-4460-b3ab-19869176b320", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "0378-3125", "generic_name": "doxepin hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA070791", "marketing_category": "ANDA", "marketing_start_date": "19860513", "listing_expiration_date": "20261231"}