Nortriptyline Hydrochloride

Orange BookUNIISPLATC N06AA10

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

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.

CountryUS (United States)

ATC codeN06AA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7071011561
100 CAPSULE in 1 BOTTLE (70710-1156-1)
ndc11
7071011563
30 CAPSULE in 1 BOTTLE (70710-1156-3)
ndc11
7071011565
500 CAPSULE in 1 BOTTLE (70710-1156-5)

Annotations

UNII (FDA Substance ID)

00FN6IH15D

NORTRIPTYLINE HYDROCHLORIDE

RxCUI 203130

Orange Book

A213441

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": "70710-1156_eb495cd8-4bb8-40f5-b578-5e5b9d49b772",
  "productndc": "70710-1156",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213441",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Feb 24, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Feb 24, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "003",
        "approval_date": "Feb 24, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 75MG BASE",
        "product_no": "004",
        "approval_date": "Feb 24, 2021"
      }
    ],
    "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": "ANDA213441",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nortriptyline Hydrochloride",
  "start_marketing_date": "20220210",
  "active_numerator_strength": "75"
}

Related drugs

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