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United States · US · US:72888-071_451e8ad6-a78e-429b-e063-6394a90a2bdb

Amitriptyline Hydrochloride

Orange BookUNIISPLATC N06AA09

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

Identification

ManufacturerAdvagen Pharma Ltd
CountryUS (United States)
ATC codeN06AA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7288807101
    100 TABLET, FILM COATED in 1 BOTTLE (72888-071-01)
  • ndc11
    7288807103
    300 TABLET, FILM COATED in 1 BOTTLE (72888-071-03)

Annotations

UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A215376
BXBXBXBXBXBX
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": "72888-071_451e8ad6-a78e-429b-e063-6394a90a2bdb",
  "productndc": "72888-071",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215376",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "May 1, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "May 1, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "May 1, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "May 1, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "May 1, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "150MG",
        "product_no": "006",
        "approval_date": "May 1, 2023"
      }
    ],
    "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": "ANDA215376",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amitriptyline Hydrochloride",
  "start_marketing_date": "20230501",
  "active_numerator_strength": "100"
}

Related drugs

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