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United States · US · US:0002-3240_aa5061b1-f237-425a-9d05-575c333dfd37

Cymbalta

Orange BookUNIISPLATC N06AX21

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeN06AX21
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
9044SC542W
DULOXETINE HYDROCHLORIDE
RxCUI 476250
Orange Book
N021427
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": {
    "2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba": {
      "match": "brand_token",
      "title": "CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]",
      "spl_version": "90",
      "published_date": "2025-08-11"
    }
  },
  "productid": "0002-3240_aa5061b1-f237-425a-9d05-575c333dfd37",
  "productndc": "0002-3240",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "021427",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Aug 3, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Aug 3, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 60MG BASE",
        "product_no": "004",
        "approval_date": "Aug 3, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DULOXETINE HYDROCHLORIDE",
  "proprietary_name": "Cymbalta",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021427",
  "marketing_category": "NDA",
  "nonproprietary_name": "Duloxetine hydrochloride",
  "start_marketing_date": "20040824",
  "active_numerator_strength": "30"
}

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