doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: lifestar pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler lifestar pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 100 mg/1

Manufacturer
Lifestar Pharma LLC

Identifiers & Regulatory

Product NDC 70756-428
Product ID 70756-428_56645f3c-452a-404f-ad51-2dab95f23e6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215710
Listing Expiration 2026-12-31
Marketing Start 2022-02-10

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70756428
Hyphenated Format 70756-428

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0370756425519 0370756424512 0370756427513
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 ANDA215710 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (70756-428-11)
  • 500 CAPSULE in 1 BOTTLE (70756-428-51)
source: ndc

Packages (2)

70756-428-11 100 CAPSULE in 1 BOTTLE (70756-428-11) 70756-428-51 500 CAPSULE in 1 BOTTLE (70756-428-51)

Ingredients (1)

doxepin hydrochloride (100 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": "56645f3c-452a-404f-ad51-2dab95f23e6e", "openfda": {"upc": ["0370756425519", "0370756424512", "0370756427513"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["fdaf3bd7-c456-40bd-8bc3-2b67eb1846c8"], "manufacturer_name": ["Lifestar Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70756-428-11)", "package_ndc": "70756-428-11", "marketing_start_date": "20220210"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (70756-428-51)", "package_ndc": "70756-428-51", "marketing_start_date": "20220210"}], "brand_name": "Doxepin Hydrochloride", "product_id": "70756-428_56645f3c-452a-404f-ad51-2dab95f23e6e", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "70756-428", "generic_name": "doxepin hydrochloride", "labeler_name": "Lifestar Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA215710", "marketing_category": "ANDA", "marketing_start_date": "20220210", "listing_expiration_date": "20261231"}