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United States · US · US:71335-9685_3544c791-cd59-40cf-e063-6394a90a362b

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 · 5

  • ndc11
    7133596851
    30 TABLET, FILM COATED in 1 BOTTLE (71335-9685-1)
  • ndc11
    7133596852
    100 TABLET, FILM COATED in 1 BOTTLE (71335-9685-2)
  • ndc11
    7133596853
    28 TABLET, FILM COATED in 1 BOTTLE (71335-9685-3)
  • ndc11
    7133596854
    60 TABLET, FILM COATED in 1 BOTTLE (71335-9685-4)
  • ndc11
    7133596855
    90 TABLET, FILM COATED in 1 BOTTLE (71335-9685-5)

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": "71335-9685_3544c791-cd59-40cf-e063-6394a90a362b",
  "productndc": "71335-9685",
  "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": "75"
}

Related drugs

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