DULOXETINE

Orange BookUNIISPLATC N06AX21

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN06AX21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7133519641
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-1)
ndc11
7133519642
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-2)
ndc11
7133519643
28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-3)
ndc11
7133519644
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-4)

Annotations

UNII (FDA Substance ID)

9044SC542W

DULOXETINE HYDROCHLORIDE

RxCUI 476250

Orange Book

A206653

ABABAB

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": "71335-1964_b4aff1e4-f7f7-4929-92fd-6c27babc38f5",
  "productndc": "71335-1964",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "206653",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "May 18, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "May 18, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "May 18, 2017"
      }
    ],
    "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": "ANDA206653",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Duloxetine",
  "start_marketing_date": "20160120",
  "active_numerator_strength": "20"
}

Related drugs

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