doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: florida pharmaceutical products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler florida pharmaceutical products, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 100 mg/1

Manufacturer
Florida Pharmaceutical Products, LLC

Identifiers & Regulatory

Product NDC 71921-166
Product ID 71921-166_ccbb860e-6367-5114-e053-2a95a90abfb9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213474
Listing Expiration 2026-12-31
Marketing Start 2021-05-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71921166
Hyphenated Format 71921-166

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0371921162017 0371921164011 0371921163014 0371921166015 0371921165018
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 ANDA213474 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (71921-166-01)
source: ndc

Packages (1)

71921-166-01 100 CAPSULE in 1 BOTTLE (71921-166-01)

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": "ccbb860e-6367-5114-e053-2a95a90abfb9", "openfda": {"upc": ["0371921162017", "0371921164011", "0371921163014", "0371921166015", "0371921165018"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["b787a283-f882-e1f0-e053-2a95a90a8975"], "manufacturer_name": ["Florida Pharmaceutical Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (71921-166-01)", "package_ndc": "71921-166-01", "marketing_start_date": "20210501"}], "brand_name": "Doxepin Hydrochloride", "product_id": "71921-166_ccbb860e-6367-5114-e053-2a95a90abfb9", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "71921-166", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Florida Pharmaceutical Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA213474", "marketing_category": "ANDA", "marketing_start_date": "20210501", "listing_expiration_date": "20261231"}