Duloxetine

Orange BookUNIISPLATC N06AX21

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN06AX21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
4733538308
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-08)
ndc11
4733538318
1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-18)
ndc11
4733538361
100 BLISTER PACK in 1 CARTON (47335-383-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
ndc11
4733538383
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-83)
ndc11
4733538388
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-88)

Annotations

UNII (FDA Substance ID)

9044SC542W

DULOXETINE HYDROCHLORIDE

RxCUI 476250

Orange Book

A090745

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": "47335-383_cec0154d-5c8c-496d-89bd-ba2a93aee774",
  "productndc": "47335-383",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "090745",
    "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": "ANDA090745",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Duloxetine",
  "start_marketing_date": "20131211",
  "active_numerator_strength": "60"
}

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