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United States · US · US:63187-396_18775e95-6eef-4cec-bf3f-3a9d5e8550d1

Nortriptyline Hydrochloride

Orange BookUNIISPLATC N06AA10

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN06AA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6318739630
    30 CAPSULE in 1 BOTTLE (63187-396-30)
  • ndc11
    6318739660
    60 CAPSULE in 1 BOTTLE (63187-396-60)
  • ndc11
    6318739690
    90 CAPSULE in 1 BOTTLE (63187-396-90)

Annotations

UNII (FDA Substance ID)
00FN6IH15D
NORTRIPTYLINE HYDROCHLORIDE
RxCUI 203130
Orange Book
A075520
ABABABAB
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": "63187-396_18775e95-6eef-4cec-bf3f-3a9d5e8550d1",
  "productndc": "63187-396",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075520",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "May 8, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "May 8, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "003",
        "approval_date": "May 8, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "004",
        "approval_date": "May 8, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NORTRIPTYLINE HYDROCHLORIDE",
  "proprietary_name": "Nortriptyline Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075520",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nortriptyline Hydrochloride",
  "start_marketing_date": "20000508",
  "active_numerator_strength": "25"
}

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