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United States · US · US:71335-1254_0f092467-7f36-1cb2-e063-6394a90a88a2

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
    7133512540
    120 TABLET, FILM COATED in 1 BOTTLE (71335-1254-0)
  • ndc11
    7133512541
    20 TABLET, FILM COATED in 1 BOTTLE (71335-1254-1)
  • ndc11
    7133512542
    30 TABLET, FILM COATED in 1 BOTTLE (71335-1254-2)
  • ndc11
    7133512543
    100 TABLET, FILM COATED in 1 BOTTLE (71335-1254-3)
  • ndc11
    7133512544
    60 TABLET, FILM COATED in 1 BOTTLE (71335-1254-4)
  • ndc11
    7133512545
    50 TABLET, FILM COATED in 1 BOTTLE (71335-1254-5)
  • ndc11
    7133512546
    90 TABLET, FILM COATED in 1 BOTTLE (71335-1254-6)
  • ndc11
    7133512547
    45 TABLET, FILM COATED in 1 BOTTLE (71335-1254-7)
  • ndc11
    7133512548
    28 TABLET, FILM COATED in 1 BOTTLE (71335-1254-8)
  • ndc11
    7133512549
    56 TABLET, FILM COATED in 1 BOTTLE (71335-1254-9)

Annotations

UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A089399
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": "71335-1254_0f092467-7f36-1cb2-e063-6394a90a88a2",
  "productndc": "71335-1254",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "089399",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jul 14, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jul 14, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Jul 14, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Jul 14, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Jul 14, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "006",
        "approval_date": "Jul 14, 1987"
      }
    ],
    "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": "ANDA089399",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amitriptyline Hydrochloride",
  "start_marketing_date": "19870714",
  "active_numerator_strength": "25"
}

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