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United States · US · US:45963-438_bda4ccaa-fa33-4911-b3bd-12391c365f47

Enulose

Orange BookUNIISPLATC A06AD11

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeA06AD11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4596343864
    473 mL in 1 BOTTLE (45963-438-64)

Annotations

UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A090502
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9U7D5QH5AE",
    "rxcui": "6218",
    "inchikey": "PFCRQPBOOFTZGQ-VZXVHDRGSA-N",
    "display_name": "LACTULOSE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL; RECTAL",
  "spl_meta": {
    "fa3aae7c-6f98-4fbb-85dc-32affe9874d5": {
      "match": "brand_token",
      "title": "ENULOSE (LACTULOSE) SOLUTION [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2024-12-20"
    }
  },
  "productid": "45963-438_bda4ccaa-fa33-4911-b3bd-12391c365f47",
  "productndc": "45963-438",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "090502",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "10GM/15ML",
        "product_no": "001",
        "approval_date": "Jan 25, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACTULOSE",
  "proprietary_name": "Enulose",
  "active_ingred_unit": "g/15mL",
  "application_number": "ANDA090502",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lactulose",
  "start_marketing_date": "20110228",
  "active_numerator_strength": "10"
}

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