doxepin

Generic: doxepin hydrochloride

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin
Generic Name doxepin hydrochloride
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxepin hydrochloride 6 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-204
Product ID 64380-204_b6b0f575-6e3a-4011-b33f-a051103058c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202510
Listing Expiration 2026-12-31
Marketing Start 2022-09-12

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380204
Hyphenated Format 64380-204

Supplemental Identifiers

RxCUI
966787 966793
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 (source: ndc)
Generic Name doxepin hydrochloride (source: ndc)
Application Number ANDA202510 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (64380-204-01)
  • 100 TABLET in 1 BOTTLE, PLASTIC (64380-204-02)
  • 500 TABLET in 1 BOTTLE, PLASTIC (64380-204-03)
source: ndc

Packages (3)

64380-204-01 30 TABLET in 1 BOTTLE, PLASTIC (64380-204-01) 64380-204-02 100 TABLET in 1 BOTTLE, PLASTIC (64380-204-02) 64380-204-03 500 TABLET in 1 BOTTLE, PLASTIC (64380-204-03)

Ingredients (1)

doxepin hydrochloride (6 mg/1)

Linked Drug Pages (1)

Doxepin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b6b0f575-6e3a-4011-b33f-a051103058c2", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["966787", "966793"], "spl_set_id": ["399866d5-3fa6-46d0-9c62-492d5997bc4f"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (64380-204-01)", "package_ndc": "64380-204-01", "marketing_start_date": "20220912"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (64380-204-02)", "package_ndc": "64380-204-02", "marketing_start_date": "20220912"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (64380-204-03)", "package_ndc": "64380-204-03", "marketing_start_date": "20220912"}], "brand_name": "Doxepin", "product_id": "64380-204_b6b0f575-6e3a-4011-b33f-a051103058c2", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "64380-204", "generic_name": "doxepin hydrochloride", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA202510", "marketing_category": "ANDA", "marketing_start_date": "20220912", "listing_expiration_date": "20261231"}