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United States · US · US:68999-002_437b8b21-3264-1b6c-e063-6294a90a1d51

Lactulose

Orange BookUNIISPLATC A06AD11

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

Identification

ManufacturerChartwell Governmental & Specialty RX, LLC.
CountryUS (United States)
ATC codeA06AD11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6899900224
    2 TRAY in 1 BOX (68999-002-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68999-002-51)

Annotations

UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A209517
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",
  "spl_meta": {
    "3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd7": {
      "match": "brand_token",
      "title": "LACTULOSE SOLUTION [CARDINAL HEALTH 107, LLC]",
      "spl_version": "11",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68999-002_437b8b21-3264-1b6c-e063-6294a90a1d51",
  "productndc": "68999-002",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "209517",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10GM/15ML",
        "product_no": "001",
        "approval_date": "Nov 23, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACTULOSE",
  "proprietary_name": "Lactulose",
  "active_ingred_unit": "g/15mL",
  "application_number": "ANDA209517",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lactulose",
  "start_marketing_date": "20181123",
  "active_numerator_strength": "10"
}

Related drugs

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