DULOXETINE

Orange BookUNIISPLATC N06AX21

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

Identification

ManufacturerSolco Healthcare US, LLC

CountryUS (United States)

ATC codeN06AX21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4354737903
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-03)
ndc11
4354737906
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-06)
ndc11
4354737909
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-09)
ndc11
4354737911
1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-11)

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": "43547-379_1b037cb5-9db9-44a6-89dd-1cf1dcf895fb",
  "productndc": "43547-379",
  "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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