doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler novadoz pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 10 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-088
Product ID 72205-088_2b1f0144-65d8-451f-8054-6be1675f102c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215113
Listing Expiration 2026-12-31
Marketing Start 2022-06-27

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205088
Hyphenated Format 72205-088

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0372205092990 0372205088917 0372205090996 0372205089990 0372205088993 0372205089914 0372205092914 0372205091917 0372205091993 0372205090910
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 ANDA215113 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (72205-088-91)
  • 1000 CAPSULE in 1 BOTTLE, PLASTIC (72205-088-99)
source: ndc

Packages (2)

72205-088-91 100 CAPSULE in 1 BOTTLE, PLASTIC (72205-088-91) 72205-088-99 1000 CAPSULE in 1 BOTTLE, PLASTIC (72205-088-99)

Ingredients (1)

doxepin hydrochloride (10 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": "2b1f0144-65d8-451f-8054-6be1675f102c", "openfda": {"upc": ["0372205092990", "0372205088917", "0372205090996", "0372205089990", "0372205088993", "0372205089914", "0372205092914", "0372205091917", "0372205091993", "0372205090910"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["2b1f0144-65d8-451f-8054-6be1675f102c"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (72205-088-91)", "package_ndc": "72205-088-91", "marketing_start_date": "20220627"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE, PLASTIC (72205-088-99)", "package_ndc": "72205-088-99", "marketing_start_date": "20220627"}], "brand_name": "Doxepin Hydrochloride", "product_id": "72205-088_2b1f0144-65d8-451f-8054-6be1675f102c", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72205-088", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA215113", "marketing_category": "ANDA", "marketing_start_date": "20220627", "listing_expiration_date": "20261231"}