doxepin hydrochloride

Generic: doxepin hydrochloride

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

Drug Facts

Product Profile

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

doxepin hydrochloride 50 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-438
Product ID 51079-438_3a3b3b4a-148f-1dc5-e063-6394a90a7bdb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070791
Listing Expiration 2026-12-31
Marketing Start 1998-05-28

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51079438
Hyphenated Format 51079-438

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076
UNII
3U9A0FE9N5

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
  • 50 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (51079-438-20) / 1 CAPSULE in 1 BLISTER PACK (51079-438-01)
source: ndc

Packages (1)

51079-438-20 100 BLISTER PACK in 1 CARTON (51079-438-20) / 1 CAPSULE in 1 BLISTER PACK (51079-438-01)

Ingredients (1)

doxepin hydrochloride (50 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": "3a3b3b4a-148f-1dc5-e063-6394a90a7bdb", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076"], "spl_set_id": ["137a953b-3c48-405f-86a6-ff778cb7f5f2"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (51079-438-20)  / 1 CAPSULE in 1 BLISTER PACK (51079-438-01)", "package_ndc": "51079-438-20", "marketing_start_date": "19980528"}], "brand_name": "Doxepin Hydrochloride", "product_id": "51079-438_3a3b3b4a-148f-1dc5-e063-6394a90a7bdb", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "51079-438", "generic_name": "doxepin hydrochloride", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA070791", "marketing_category": "ANDA", "marketing_start_date": "19980528", "listing_expiration_date": "20261231"}