Nortriptyline Hydrochloride

Orange BookUNIISPLATC N06AA10

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

Identification

ManufacturerPAI Holdings, LLC dba PAI Pharma

CountryUS (United States)

ATC codeN06AA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0121067816
473 mL in 1 BOTTLE (0121-0678-16)

Annotations

UNII (FDA Substance ID)

00FN6IH15D

NORTRIPTYLINE HYDROCHLORIDE

RxCUI 203130

Orange Book

A075606

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "00FN6IH15D",
    "rxcui": "203130",
    "inchikey": "SHAYBENGXDALFF-UHFFFAOYSA-N",
    "display_name": "NORTRIPTYLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "21770082-7a99-520d-e063-6394a90ab9cb": {
      "match": "brand_token",
      "title": "NORTRIPTYLINE HYDROCHLORIDE CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]",
      "spl_version": "4",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0121-0678_49445e55-d381-44c5-9e91-392f530d6dfc",
  "productndc": "0121-0678",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "075606",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 10MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Aug 23, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NORTRIPTYLINE HYDROCHLORIDE",
  "proprietary_name": "Nortriptyline Hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA075606",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nortriptyline Hydrochloride",
  "start_marketing_date": "20000823",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06AA10.

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