doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler chartwell rx, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 50 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-562
Product ID 62135-562_459bacaf-9b0a-6657-e063-6394a90a66cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210268
Listing Expiration 2026-12-31
Marketing Start 2020-09-04

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135562
Hyphenated Format 62135-562

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0362135561901 0362135562908 0362135564902 0362135560904 0362135563905
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 ANDA210268 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (62135-562-90)
source: ndc

Packages (1)

62135-562-90 90 CAPSULE in 1 BOTTLE (62135-562-90)

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": "459bacaf-9b0a-6657-e063-6394a90a66cf", "openfda": {"upc": ["0362135561901", "0362135562908", "0362135564902", "0362135560904", "0362135563905"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["33a15c3f-bec0-4703-a4e9-f8f78f8b5fd3"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "90 CAPSULE in 1 BOTTLE (62135-562-90)", "package_ndc": "62135-562-90", "marketing_start_date": "20221122"}], "brand_name": "Doxepin Hydrochloride", "product_id": "62135-562_459bacaf-9b0a-6657-e063-6394a90a66cf", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "62135-562", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA210268", "marketing_category": "ANDA", "marketing_start_date": "20200904", "listing_expiration_date": "20261231"}