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United States · US · US:47335-618_67134e3c-1819-4262-a36f-460afdbb165d

DRIZALMA SPRINKLE

Orange BookUNIISPLATC N06AX21

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

Identification

ManufacturerSUN PHARMACEUTICAL INDUSTRIES, INC.
CountryUS (United States)
ATC codeN06AX21
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    4733561810
    1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-618-10)
  • ndc11
    4733561830
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-618-30)
  • ndc11
    4733561860
    60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-618-60)
  • ndc11
    4733561890
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-618-90)

Annotations

UNII (FDA Substance ID)
9044SC542W
DULOXETINE HYDROCHLORIDE
RxCUI 476250
Orange Book
N212516
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": {
    "b41423b8-dfec-4d79-ba3c-e43a87803d85": {
      "match": "brand_token",
      "title": "DRIZALMA SPRINKLE (DULOXETINE) CAPSULE, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "6",
      "published_date": "2024-06-11"
    }
  },
  "productid": "47335-618_67134e3c-1819-4262-a36f-460afdbb165d",
  "productndc": "47335-618",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "212516",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 60MG BASE",
        "product_no": "004",
        "approval_date": "Jul 19, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DULOXETINE HYDROCHLORIDE",
  "proprietary_name": "DRIZALMA SPRINKLE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA212516",
  "marketing_category": "NDA",
  "nonproprietary_name": "Duloxetine",
  "start_marketing_date": "20240610",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code N06AX21.

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