Atomoxetine

Orange BookUNIISPLATC N06BA09

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

Identification

ManufacturerDr. Reddy's Laboratories Limited

CountryUS (United States)

ATC codeN06BA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5511156405
500 CAPSULE in 1 BOTTLE (55111-564-05)
ndc11
5511156430
30 CAPSULE in 1 BOTTLE (55111-564-30)
ndc11
5511156478
100 BLISTER PACK in 1 CARTON (55111-564-78) / 10 CAPSULE in 1 BLISTER PACK (55111-564-79)

Annotations

UNII (FDA Substance ID)

57WVB6I2W0

ATOMOXETINE HYDROCHLORIDE

RxCUI 353103

Orange Book

A090609

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": "55111-564_d266ad8b-af60-8e42-149b-e881323543a5",
  "productndc": "55111-564",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "090609",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Feb 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 18MG BASE",
        "product_no": "002",
        "approval_date": "Feb 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "003",
        "approval_date": "Feb 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Feb 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "005",
        "approval_date": "Feb 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "006",
        "approval_date": "Feb 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "007",
        "approval_date": "Feb 23, 2018"
      }
    ],
    "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": "ANDA090609",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atomoxetine",
  "start_marketing_date": "20180223",
  "active_numerator_strength": "100"
}

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