atomoxetine

Orange BookUNIISPLATC N06BA09

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN06BA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6838221802
2000 CAPSULE in 1 BOTTLE (68382-218-02)
ndc11
6838221806
30 CAPSULE in 1 BOTTLE (68382-218-06)
ndc11
6838221810
1000 CAPSULE in 1 BOTTLE (68382-218-10)
ndc11
6838221814
60 CAPSULE in 1 BOTTLE (68382-218-14)
ndc11
6838221816
90 CAPSULE in 1 BOTTLE (68382-218-16)
ndc11
6838221877
10 BLISTER PACK in 1 CARTON (68382-218-77) / 10 CAPSULE in 1 BLISTER PACK (68382-218-30)

Annotations

UNII (FDA Substance ID)

57WVB6I2W0

ATOMOXETINE HYDROCHLORIDE

RxCUI 353103

Orange Book

A079017

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": "68382-218_8e543a65-7611-4362-94ba-0b3f929c776c",
  "productndc": "68382-218",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "079017",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 18MG BASE",
        "product_no": "001",
        "approval_date": "Sep 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Sep 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Sep 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "004",
        "approval_date": "Sep 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "005",
        "approval_date": "Sep 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "006",
        "approval_date": "Sep 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "007",
        "approval_date": "Apr 5, 2023"
      }
    ],
    "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": "ANDA079017",
  "marketing_category": "ANDA",
  "nonproprietary_name": "atomoxetine",
  "start_marketing_date": "20170612",
  "active_numerator_strength": "40"
}

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