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United States · US · US:70771-1529_2a2843b4-5867-4df6-af9a-dbe0264d6f1b

doxepin

Orange BookUNIISPLATC D04AX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeD04AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7077115290
    1000 TABLET in 1 BOTTLE (70771-1529-0)
  • ndc11
    7077115291
    100 TABLET in 1 BOTTLE (70771-1529-1)
  • ndc11
    7077115293
    30 TABLET in 1 BOTTLE (70771-1529-3)
  • ndc11
    7077115294
    10 BLISTER PACK in 1 CARTON (70771-1529-4) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    7077115295
    500 TABLET in 1 BOTTLE (70771-1529-5)
  • ndc11
    7077115299
    90 TABLET in 1 BOTTLE (70771-1529-9)

Annotations

UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A202761
ABAB
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": "70771-1529_2a2843b4-5867-4df6-af9a-dbe0264d6f1b",
  "productndc": "70771-1529",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202761",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 3MG BASE",
        "product_no": "001",
        "approval_date": "Aug 16, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 6MG BASE",
        "product_no": "002",
        "approval_date": "Aug 16, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXEPIN HYDROCHLORIDE",
  "proprietary_name": "doxepin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202761",
  "marketing_category": "ANDA",
  "nonproprietary_name": "doxepin",
  "start_marketing_date": "20240630",
  "active_numerator_strength": "6"
}

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