Duloxetine

Orange BookUNIISPLATC N06AX21

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

Identification

ManufacturerMARKSANS PHARMA LIMITED

CountryUS (United States)

ATC codeN06AX21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
2500061003
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-610-03)
ndc11
2500061007
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-610-07)

Annotations

UNII (FDA Substance ID)

9044SC542W

DULOXETINE HYDROCHLORIDE

RxCUI 476250

Orange Book

A090723

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": "25000-610_c8aa863f-eb1f-4b66-9ec6-2af2c7958248",
  "productndc": "25000-610",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "090723",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Dec 11, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Dec 11, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Dec 11, 2013"
      }
    ],
    "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": "ANDA090723",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Duloxetine Hydrochloride",
  "start_marketing_date": "20220527",
  "active_numerator_strength": "60"
}

Related drugs

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