Doxepin Hydrochloride

Orange BookUNIISPLATC D04AX01

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

Identification

ManufacturerEndo USA, Inc.

CountryUS (United States)

ATC codeD04AX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4988422201
100 CAPSULE in 1 BOTTLE (49884-222-01)
ndc11
4988422203
50 CAPSULE in 1 BOTTLE (49884-222-03)
ndc11
4988422205
500 CAPSULE in 1 BOTTLE (49884-222-05)

Annotations

UNII (FDA Substance ID)

3U9A0FE9N5

DOXEPIN HYDROCHLORIDE

RxCUI 203179

Orange Book

A071422

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": "49884-222_75a2a220-95ff-4c6a-aa58-15e3352b6e7f",
  "productndc": "49884-222",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "071422",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Nov 9, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Nov 9, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 25MG BASE",
        "product_no": "003",
        "approval_date": "Nov 9, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "004",
        "approval_date": "Nov 9, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 75MG BASE",
        "product_no": "005",
        "approval_date": "Nov 9, 1987"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "006",
        "approval_date": "Nov 9, 1987"
      }
    ],
    "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": "ANDA071422",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxepin Hydrochloride",
  "start_marketing_date": "19871109",
  "active_numerator_strength": "150"
}

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