Atomoxetine

Orange BookUNIISPLATC N06BA09

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

Identification

ManufacturerStrides Pharma Science Limited

CountryUS (United States)

ATC codeN06BA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6438047501
30 CAPSULE in 1 BOTTLE, PLASTIC (64380-475-01)
ndc11
6438047502
500 CAPSULE in 1 BOTTLE, PLASTIC (64380-475-02)

Annotations

UNII (FDA Substance ID)

57WVB6I2W0

ATOMOXETINE HYDROCHLORIDE

RxCUI 353103

Orange Book

A079021

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": "64380-475_94ef88bd-e176-4c16-9340-ae0168422053",
  "productndc": "64380-475",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "079021",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Feb 18, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 18MG BASE",
        "product_no": "002",
        "approval_date": "Feb 18, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "003",
        "approval_date": "Feb 18, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Feb 18, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "005",
        "approval_date": "Feb 18, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "006",
        "approval_date": "Feb 18, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "007",
        "approval_date": "Feb 18, 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": "ANDA079021",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atomoxetine",
  "start_marketing_date": "20250701",
  "active_numerator_strength": "40"
}

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