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United States · US · US:0002-3227_8360d9e6-0df4-4969-9efa-7c01e69d6947

Strattera

Orange BookUNIISPLATC N06BA09

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

Identification

ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeN06BA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0002322730
    30 CAPSULE in 1 BOTTLE (0002-3227-30)

Annotations

UNII (FDA Substance ID)
57WVB6I2W0
ATOMOXETINE HYDROCHLORIDE
RxCUI 353103
Orange Book
N021411
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": {
    "309de576-c318-404a-bc15-660c2b1876fb": {
      "match": "brand_token",
      "title": "STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY\n]",
      "spl_version": "66",
      "published_date": "2026-02-05"
    }
  },
  "productid": "0002-3227_8360d9e6-0df4-4969-9efa-7c01e69d6947",
  "productndc": "0002-3227",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021411",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Nov 26, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Nov 26, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Nov 26, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Nov 26, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Nov 26, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Nov 26, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "007",
        "approval_date": "Feb 14, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "008",
        "approval_date": "Feb 14, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOMOXETINE HYDROCHLORIDE",
  "proprietary_name": "Strattera",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021411",
  "marketing_category": "NDA",
  "nonproprietary_name": "Atomoxetine hydrochloride",
  "start_marketing_date": "20021126",
  "active_numerator_strength": "10"
}

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