Duloxetine

Orange BookUNIISPLATC N06AX21

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

Identification

ManufacturerPreferred Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN06AX21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6878876720
6 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-0)
ndc11
6878876721
10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-1)
ndc11
6878876722
20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-2)
ndc11
6878876723
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-3)
ndc11
6878876726
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-6)
ndc11
6878876728
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-8)
ndc11
6878876729
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-9)

Annotations

UNII (FDA Substance ID)

9044SC542W

DULOXETINE HYDROCHLORIDE

RxCUI 476250

Orange Book

A208706

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9044SC542W",
    "rxcui": "476250",
    "inchikey": "BFFSMCNJSOPUAY-LMOVPXPDSA-N",
    "display_name": "DULOXETINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9dab9154-b86f-40dc-a4d1-18e6534dbc78": {
      "match": "brand_token",
      "title": "DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]",
      "spl_version": "28",
      "published_date": "2026-05-20"
    }
  },
  "productid": "68788-7672_707ee23e-19a5-4e39-be4d-e262442a34a6",
  "productndc": "68788-7672",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "208706",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jan 6, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Jan 6, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Jan 6, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Mar 11, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DULOXETINE HYDROCHLORIDE",
  "proprietary_name": "Duloxetine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208706",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Duloxetine",
  "start_marketing_date": "20200228",
  "active_numerator_strength": "60"
}

Related drugs

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