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United States · US · US:16714-260_f089e8f9-aed0-4f80-812d-35a969447345

Amitriptyline Hydrochloride

Orange BookUNIISPLATC N06AA09

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

Identification

ManufacturerNorthstar Rx LLC.
CountryUS (United States)
ATC codeN06AA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1671426001
    100 TABLET, FILM COATED in 1 BOTTLE (16714-260-01)

Annotations

UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A210086
ABABABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "26LUD4JO9K",
    "rxcui": "203168",
    "inchikey": "KFYRPLNVJVHZGT-UHFFFAOYSA-N",
    "display_name": "AMITRIPTYLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ce87013b-bf4a-47d1-9808-7cb8290feb23": {
      "match": "brand_token",
      "title": "AMITRIPTYLINE HYDROCHLORIDE TABLET, COATED [REMEDYREPACK INC.]",
      "spl_version": "5",
      "published_date": "2026-05-04"
    }
  },
  "productid": "16714-260_f089e8f9-aed0-4f80-812d-35a969447345",
  "productndc": "16714-260",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210086",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 6, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Oct 6, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Oct 6, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Oct 6, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Oct 6, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "006",
        "approval_date": "Oct 6, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMITRIPTYLINE HYDROCHLORIDE",
  "proprietary_name": "Amitriptyline Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210086",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amitriptyline Hydrochloride",
  "start_marketing_date": "20210825",
  "active_numerator_strength": "75"
}

Related drugs

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