Back to search
🇺🇸

United States · US · US:62135-004_49798265-6d70-8bc1-e063-6394a90a59d4

Lactulose

Orange BookUNIISPLATC A06AD11

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

Identification

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

Packs · 1

  • ndc11
    6213500424
    2 TRAY in 1 BOX (62135-004-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (62135-004-43)

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": "62135-004_49798265-6d70-8bc1-e063-6394a90a59d4",
  "productndc": "62135-004",
  "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

Other records sharing ATC code A06AD11.

Access this data programmatically

Query Lactulose and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.