Doxepin Hydrochloride

Orange BookUNIISPLATC D04AX01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSafecor Health, LLC

CountryUS (United States)

ATC codeD04AX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4843303620
100 BLISTER PACK in 1 CARTON (48433-036-20) / 1 CAPSULE in 1 BLISTER PACK (48433-036-01)

Annotations

UNII (FDA Substance ID)

3U9A0FE9N5

DOXEPIN HYDROCHLORIDE

RxCUI 203179

Orange Book

A070791

ABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3U9A0FE9N5",
    "rxcui": "203179",
    "inchikey": null,
    "display_name": "DOXEPIN HYDROCHLORIDE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "89ed6385-cf6a-458e-81ea-c7f3fead41c5": {
      "match": "brand_token",
      "title": "DOXEPIN HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
      "spl_version": "2",
      "published_date": "2026-05-13"
    }
  },
  "productid": "48433-036_4c4c90ec-fb2d-e45d-e063-6294a90a419a",
  "productndc": "48433-036",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "070791",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "May 13, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "May 13, 1986"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "003",
        "approval_date": "May 13, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "004",
        "approval_date": "May 13, 1986"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "005",
        "approval_date": "May 13, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXEPIN HYDROCHLORIDE",
  "proprietary_name": "Doxepin Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA070791",
  "marketing_category": "ANDA",
  "nonproprietary_name": "doxepin hydrochloride",
  "start_marketing_date": "20260223",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code D04AX01.

Access this data programmatically

Query Doxepin Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs