DULOXETINE HYDROCHLORIDE

Orange BookUNIISPLATC N06AX21

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

Identification

ManufacturerYaopharma Co., Ltd.

CountryUS (United States)

ATC codeN06AX21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5077120201
90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-202-01)
ndc11
5077120202
1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-202-02)

Annotations

UNII (FDA Substance ID)

9044SC542W

DULOXETINE HYDROCHLORIDE

RxCUI 476250

Orange Book

A207219

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": "50771-202_4502c810-4eb5-29c4-e063-6394a90aefe4",
  "productndc": "50771-202",
  "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS",
  "orange_book": {
    "appl_no": "207219",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Aug 16, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Aug 16, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Aug 16, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DULOXETINE HYDROCHLORIDE",
  "proprietary_name": "DULOXETINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207219",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DULOXETINE HYDROCHLORIDE",
  "start_marketing_date": "20240101",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code N06AX21.

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