PAMELOR

Orange BookUNIISPLATC N06AA10

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

Identification

ManufacturerSpecGx LLC

CountryUS (United States)

ATC codeN06AA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0406991303
30 CAPSULE in 1 BOTTLE (0406-9913-03)

Annotations

UNII (FDA Substance ID)

00FN6IH15D

NORTRIPTYLINE HYDROCHLORIDE

RxCUI 203130

Orange Book

N018013

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": {
    "e17dc299-f52d-414d-ab6e-e809bd6f8acb": {
      "match": "brand_token",
      "title": "PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [SPECGX LLC]",
      "spl_version": "24",
      "published_date": "2025-09-22"
    }
  },
  "productid": "0406-9913_0c3b20b3-e852-4959-815a-90ed989a30e1",
  "productndc": "0406-9913",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "018013",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 75MG BASE",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NORTRIPTYLINE HYDROCHLORIDE",
  "proprietary_name": "PAMELOR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018013",
  "marketing_category": "NDA",
  "nonproprietary_name": "nortriptyline hydrochloride",
  "start_marketing_date": "19770801",
  "active_numerator_strength": "75"
}

Related drugs

Other records sharing ATC code N06AA10.

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