Atomoxetine Hydrochloride

Orange BookUNIISPLATC N06BA09

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

Identification

ManufacturerApotex Corp.

CountryUS (United States)

ATC codeN06BA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050528333
30 CAPSULE in 1 BOTTLE (60505-2833-3)

Annotations

UNII (FDA Substance ID)

57WVB6I2W0

ATOMOXETINE HYDROCHLORIDE

RxCUI 353103

Orange Book

A078983

ABABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "57WVB6I2W0",
    "rxcui": "353103",
    "inchikey": "LUCXVPAZUDVVBT-UNTBIKODSA-N",
    "display_name": "ATOMOXETINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f266ab7b-5a68-42b5-b204-e3249bea0aed": {
      "match": "brand_token",
      "title": "ATOMOXETINE (ATOMOXETINE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-05-26"
    }
  },
  "productid": "60505-2833_ad1d5a70-74b7-c5db-b589-88081ba704f9",
  "productndc": "60505-2833",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "078983",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "May 30, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 18MG BASE",
        "product_no": "002",
        "approval_date": "May 30, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "003",
        "approval_date": "May 30, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "May 30, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "005",
        "approval_date": "May 30, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "006",
        "approval_date": "May 30, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "007",
        "approval_date": "May 30, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOMOXETINE HYDROCHLORIDE",
  "proprietary_name": "Atomoxetine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078983",
  "marketing_category": "ANDA",
  "nonproprietary_name": "atomoxetine hydrochloride",
  "start_marketing_date": "20180521",
  "active_numerator_strength": "40"
}

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