Duloxetine

Orange BookUNIISPLATC N06AX21

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeN06AX21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7642062300
1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-623-00)
ndc11
7642062301
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-623-01)
ndc11
7642062320
20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-623-20)
ndc11
7642062330
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-623-30)
ndc11
7642062360
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-623-60)
ndc11
7642062390
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-623-90)

Annotations

UNII (FDA Substance ID)

9044SC542W

DULOXETINE HYDROCHLORIDE

RxCUI 476250

Orange Book

A208706

ABABABAB

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": "76420-623_31e2603c-b629-1f0d-e063-6294a90a3646",
  "productndc": "76420-623",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "208706",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jan 6, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Jan 6, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Jan 6, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Mar 11, 2019"
      }
    ],
    "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": "ANDA208706",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Duloxetine",
  "start_marketing_date": "20170316",
  "active_numerator_strength": "60"
}

Related drugs

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