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United States · US · US:71335-9633_62cc9302-bbfa-4d7c-bf63-d6cc2d10e026

Amitriptyline Hydrochloride

Orange BookUNIISPLATC N06AA09

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

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
    7133596330
    120 TABLET, FILM COATED in 1 BOTTLE (71335-9633-0)
  • ndc11
    7133596331
    20 TABLET, FILM COATED in 1 BOTTLE (71335-9633-1)
  • ndc11
    7133596332
    30 TABLET, FILM COATED in 1 BOTTLE (71335-9633-2)
  • ndc11
    7133596333
    100 TABLET, FILM COATED in 1 BOTTLE (71335-9633-3)
  • ndc11
    7133596334
    60 TABLET, FILM COATED in 1 BOTTLE (71335-9633-4)
  • ndc11
    7133596335
    50 TABLET, FILM COATED in 1 BOTTLE (71335-9633-5)
  • ndc11
    7133596336
    90 TABLET, FILM COATED in 1 BOTTLE (71335-9633-6)
  • ndc11
    7133596337
    45 TABLET, FILM COATED in 1 BOTTLE (71335-9633-7)
  • ndc11
    7133596338
    28 TABLET, FILM COATED in 1 BOTTLE (71335-9633-8)
  • ndc11
    7133596339
    56 TABLET, FILM COATED in 1 BOTTLE (71335-9633-9)

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": "71335-9633_62cc9302-bbfa-4d7c-bf63-d6cc2d10e026",
  "productndc": "71335-9633",
  "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": "25"
}

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