doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 75 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-597
Product ID 64980-597_2877d1f2-a036-4577-926d-b09828350ea1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217975
Listing Expiration 2026-12-31
Marketing Start 2023-12-25

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980597
Hyphenated Format 64980-597

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0364980594011 0364980597012 0364980595018 0364980596015 0364980598019
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 ANDA217975 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (64980-597-01)
source: ndc

Packages (1)

64980-597-01 100 CAPSULE in 1 BOTTLE (64980-597-01)

Ingredients (1)

doxepin hydrochloride (75 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": "2877d1f2-a036-4577-926d-b09828350ea1", "openfda": {"upc": ["0364980594011", "0364980597012", "0364980595018", "0364980596015", "0364980598019"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["66c6af99-9909-4b18-a43b-898a1c4a34d7"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (64980-597-01)", "package_ndc": "64980-597-01", "marketing_start_date": "20231225"}], "brand_name": "Doxepin hydrochloride", "product_id": "64980-597_2877d1f2-a036-4577-926d-b09828350ea1", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "64980-597", "generic_name": "Doxepin hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "75 mg/1"}], "application_number": "ANDA217975", "marketing_category": "ANDA", "marketing_start_date": "20231225", "listing_expiration_date": "20261231"}