duloxetine

Orange BookUNIISPLATC N06AX21

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

Identification

ManufacturerInventia Healthcare Limited.

CountryUS (United States)

ATC codeN06AX21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
4925200810
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-10)
ndc11
4925200811
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-11)
ndc11
4925200812
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-12)
ndc11
4925200818
1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-18)
ndc11
4925200857
100 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (49252-008-57)

Annotations

UNII (FDA Substance ID)

9044SC542W

DULOXETINE HYDROCHLORIDE

RxCUI 476250

Orange Book

A202336

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": "49252-008_3fb45d3e-3fbc-8814-e063-6294a90a4a70",
  "productndc": "49252-008",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "202336",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Oct 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Oct 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Oct 28, 2015"
      }
    ],
    "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": "ANDA202336",
  "marketing_category": "ANDA",
  "nonproprietary_name": "duloxetine",
  "start_marketing_date": "20151205",
  "active_numerator_strength": "30"
}

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