doxepin

Generic: doxepin

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin
Generic Name doxepin
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxepin hydrochloride 3 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1528
Product ID 70771-1528_2a2843b4-5867-4df6-af9a-dbe0264d6f1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202761
Listing Expiration 2026-12-31
Marketing Start 2024-06-30

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711528
Hyphenated Format 70771-1528

Supplemental Identifiers

RxCUI
966787 966793
UPC
0372578182069 0372578181062
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 (source: ndc)
Generic Name doxepin (source: ndc)
Application Number ANDA202761 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70771-1528-0)
  • 100 TABLET in 1 BOTTLE (70771-1528-1)
  • 30 TABLET in 1 BOTTLE (70771-1528-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1528-4) / 10 TABLET in 1 BLISTER PACK
  • 500 TABLET in 1 BOTTLE (70771-1528-5)
  • 90 TABLET in 1 BOTTLE (70771-1528-9)
source: ndc

Packages (6)

70771-1528-0 1000 TABLET in 1 BOTTLE (70771-1528-0) 70771-1528-1 100 TABLET in 1 BOTTLE (70771-1528-1) 70771-1528-3 30 TABLET in 1 BOTTLE (70771-1528-3) 70771-1528-4 10 BLISTER PACK in 1 CARTON (70771-1528-4) / 10 TABLET in 1 BLISTER PACK 70771-1528-5 500 TABLET in 1 BOTTLE (70771-1528-5) 70771-1528-9 90 TABLET in 1 BOTTLE (70771-1528-9)

Ingredients (1)

doxepin hydrochloride (3 mg/1)

Linked Drug Pages (1)

doxepin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a2843b4-5867-4df6-af9a-dbe0264d6f1b", "openfda": {"upc": ["0372578182069", "0372578181062"], "unii": ["3U9A0FE9N5"], "rxcui": ["966787", "966793"], "spl_set_id": ["1461ede6-24f0-42a1-b801-0cf4ef404985"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1528-0)", "package_ndc": "70771-1528-0", "marketing_start_date": "20240630"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1528-1)", "package_ndc": "70771-1528-1", "marketing_start_date": "20240630"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70771-1528-3)", "package_ndc": "70771-1528-3", "marketing_start_date": "20240630"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1528-4)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70771-1528-4", "marketing_start_date": "20240630"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70771-1528-5)", "package_ndc": "70771-1528-5", "marketing_start_date": "20240630"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70771-1528-9)", "package_ndc": "70771-1528-9", "marketing_start_date": "20240630"}], "brand_name": "doxepin", "product_id": "70771-1528_2a2843b4-5867-4df6-af9a-dbe0264d6f1b", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "70771-1528", "generic_name": "doxepin", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "doxepin", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "3 mg/1"}], "application_number": "ANDA202761", "marketing_category": "ANDA", "marketing_start_date": "20240630", "listing_expiration_date": "20261231"}