doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler alembic pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 25 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-638
Product ID 62332-638_c3977b05-a9fc-4cc4-adfc-731abe6613dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215076
Listing Expiration 2026-12-31
Marketing Start 2021-04-23

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332638
Hyphenated Format 62332-638

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0362332645312
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 ANDA215076 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (62332-638-31)
  • 1000 CAPSULE in 1 BOTTLE (62332-638-91)
source: ndc

Packages (2)

62332-638-31 100 CAPSULE in 1 BOTTLE (62332-638-31) 62332-638-91 1000 CAPSULE in 1 BOTTLE (62332-638-91)

Ingredients (1)

doxepin hydrochloride (25 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": "c3977b05-a9fc-4cc4-adfc-731abe6613dd", "openfda": {"upc": ["0362332645312"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["4920401a-cde5-404b-82aa-c3c0e8911065"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (62332-638-31)", "package_ndc": "62332-638-31", "marketing_start_date": "20210423"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (62332-638-91)", "package_ndc": "62332-638-91", "marketing_start_date": "20210423"}], "brand_name": "DOXEPIN HYDROCHLORIDE", "product_id": "62332-638_c3977b05-a9fc-4cc4-adfc-731abe6613dd", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "62332-638", "generic_name": "DOXEPIN HYDROCHLORIDE", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOXEPIN HYDROCHLORIDE", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA215076", "marketing_category": "ANDA", "marketing_start_date": "20210423", "listing_expiration_date": "20261231"}