DOXEPIN HYDROCHLORIDE

Orange BookUNIISPLATC D04AX01

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeD04AX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4670863831
100 CAPSULE in 1 BOTTLE (46708-638-31)
ndc11
4670863891
1000 CAPSULE in 1 BOTTLE (46708-638-91)

Annotations

UNII (FDA Substance ID)

3U9A0FE9N5

DOXEPIN HYDROCHLORIDE

RxCUI 203179

Orange Book

A215076

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": "46708-638_5c5c56f2-76f7-41b1-8eb5-40dc4cd4ac6a",
  "productndc": "46708-638",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215076",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Apr 21, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Apr 21, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "003",
        "approval_date": "Apr 21, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "004",
        "approval_date": "Apr 21, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "005",
        "approval_date": "Apr 21, 2021"
      }
    ],
    "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": "ANDA215076",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DOXEPIN HYDROCHLORIDE",
  "start_marketing_date": "20210423",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code D04AX01.

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