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 · 10

ndc11
7133503950
100 TABLET, FILM COATED in 1 BOTTLE (71335-0395-0)
ndc11
7133503951
30 TABLET, FILM COATED in 1 BOTTLE (71335-0395-1)
ndc11
7133503952
15 TABLET, FILM COATED in 1 BOTTLE (71335-0395-2)
ndc11
7133503953
60 TABLET, FILM COATED in 1 BOTTLE (71335-0395-3)
ndc11
7133503954
90 TABLET, FILM COATED in 1 BOTTLE (71335-0395-4)
ndc11
7133503955
28 TABLET, FILM COATED in 1 BOTTLE (71335-0395-5)
ndc11
7133503956
120 TABLET, FILM COATED in 1 BOTTLE (71335-0395-6)
ndc11
7133503957
50 TABLET, FILM COATED in 1 BOTTLE (71335-0395-7)
ndc11
7133503958
180 TABLET, FILM COATED in 1 BOTTLE (71335-0395-8)
ndc11
7133503959
6 TABLET, FILM COATED in 1 BOTTLE (71335-0395-9)

Annotations

UNII (FDA Substance ID)

26LUD4JO9K

AMITRIPTYLINE HYDROCHLORIDE

RxCUI 203168

Orange Book

A202446

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": "71335-0395_40f41ec8-0357-4851-82f1-0a94ee15a24a",
  "productndc": "71335-0395",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202446",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 4, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jun 4, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Jun 4, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Jun 4, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Jun 4, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "006",
        "approval_date": "Jun 4, 2014"
      }
    ],
    "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": "ANDA202446",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMITRIPTYLINE HYDROCHLORIDE",
  "start_marketing_date": "20141205",
  "active_numerator_strength": "10"
}

Related drugs

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