Doxepin Hydrochloride

Orange BookUNIISPLATC D04AX01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeD04AX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7133524081
60 CAPSULE in 1 BOTTLE (71335-2408-1)
ndc11
7133524082
30 CAPSULE in 1 BOTTLE (71335-2408-2)
ndc11
7133524083
90 CAPSULE in 1 BOTTLE (71335-2408-3)
ndc11
7133524084
120 CAPSULE in 1 BOTTLE (71335-2408-4)

Annotations

UNII (FDA Substance ID)

3U9A0FE9N5

DOXEPIN HYDROCHLORIDE

RxCUI 203179

Orange Book

A213474

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": "71335-2408_8e5a9620-a6e9-402a-aa93-da77ff5c8d98",
  "productndc": "71335-2408",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213474",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jul 28, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Jul 28, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "003",
        "approval_date": "Jul 28, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "004",
        "approval_date": "Jul 28, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "005",
        "approval_date": "Jul 28, 2020"
      }
    ],
    "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": "ANDA213474",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxepin Hydrochloride",
  "start_marketing_date": "20210501",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code D04AX01.

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