doxepin hydrochloride

Generic: doxepin hydrochloride

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

Drug Facts

Product Profile

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

doxepin hydrochloride 100 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-640
Product ID 46708-640_5c5c56f2-76f7-41b1-8eb5-40dc4cd4ac6a
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 46708640
Hyphenated Format 46708-640

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0346708638313 0346708639310
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
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (46708-640-31)
  • 1000 CAPSULE in 1 BOTTLE (46708-640-91)
source: ndc

Packages (2)

46708-640-31 100 CAPSULE in 1 BOTTLE (46708-640-31) 46708-640-91 1000 CAPSULE in 1 BOTTLE (46708-640-91)

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": "5c5c56f2-76f7-41b1-8eb5-40dc4cd4ac6a", "openfda": {"upc": ["0346708638313", "0346708639310"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["842b595b-dc54-4898-a178-1d2241cc065f"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (46708-640-31)", "package_ndc": "46708-640-31", "marketing_start_date": "20210423"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (46708-640-91)", "package_ndc": "46708-640-91", "marketing_start_date": "20210423"}], "brand_name": "DOXEPIN HYDROCHLORIDE", "product_id": "46708-640_5c5c56f2-76f7-41b1-8eb5-40dc4cd4ac6a", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "46708-640", "generic_name": "DOXEPIN HYDROCHLORIDE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOXEPIN HYDROCHLORIDE", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA215076", "marketing_category": "ANDA", "marketing_start_date": "20210423", "listing_expiration_date": "20261231"}