Atomoxetine

Orange BookUNIISPLATC N06BA09

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

Identification

ManufacturerNorthStar RxLLC

CountryUS (United States)

ATC codeN06BA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7260343701
30 CAPSULE in 1 BOTTLE (72603-437-01)

Annotations

UNII (FDA Substance ID)

57WVB6I2W0

ATOMOXETINE HYDROCHLORIDE

RxCUI 353103

Orange Book

A202682

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": "72603-437_47f097ff-7152-f861-e063-6294a90a795a",
  "productndc": "72603-437",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "202682",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Mar 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 18MG BASE",
        "product_no": "002",
        "approval_date": "Mar 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "003",
        "approval_date": "Mar 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Mar 11, 2021"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "005",
        "approval_date": "Mar 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "006",
        "approval_date": "Mar 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "007",
        "approval_date": "Mar 11, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOMOXETINE HYDROCHLORIDE",
  "proprietary_name": "Atomoxetine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202682",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atomoxetine",
  "start_marketing_date": "20260302",
  "active_numerator_strength": "25"
}

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