Amitriptyline Hydrochloride

Orange BookUNIISPLATC N06AA09

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN06AA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7133596351
100 TABLET, FILM COATED in 1 BOTTLE (71335-9635-1)
ndc11
7133596352
30 TABLET, FILM COATED in 1 BOTTLE (71335-9635-2)
ndc11
7133596353
60 TABLET, FILM COATED in 1 BOTTLE (71335-9635-3)
ndc11
7133596354
90 TABLET, FILM COATED in 1 BOTTLE (71335-9635-4)
ndc11
7133596355
20 TABLET, FILM COATED in 1 BOTTLE (71335-9635-5)
ndc11
7133596356
28 TABLET, FILM COATED in 1 BOTTLE (71335-9635-6)
ndc11
7133596357
56 TABLET, FILM COATED in 1 BOTTLE (71335-9635-7)
ndc11
7133596358
180 TABLET, FILM COATED in 1 BOTTLE (71335-9635-8)

Annotations

UNII (FDA Substance ID)

26LUD4JO9K

AMITRIPTYLINE HYDROCHLORIDE

RxCUI 203168

Orange Book

A214548

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": "71335-9635_f1f451d3-722f-480e-9cfb-4ee6b6daf359",
  "productndc": "71335-9635",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214548",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "May 19, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "May 19, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "May 19, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "May 19, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "May 19, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "006",
        "approval_date": "May 19, 2021"
      }
    ],
    "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": "ANDA214548",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amitriptyline Hydrochloride",
  "start_marketing_date": "20210526",
  "active_numerator_strength": "50"
}

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