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United States · US · US:0527-5125_1b869904-b3c5-4f81-a333-1f26b6b2c7bf

LACTULOSE

Orange BookUNIISPLATC A06AD11

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

Identification

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

Packs · 4

  • ndc11
    0527512568
    237 mL in 1 BOTTLE (0527-5125-68)
  • ndc11
    0527512570
    473 mL in 1 BOTTLE (0527-5125-70)
  • ndc11
    0527512578
    946 mL in 1 BOTTLE (0527-5125-78)
  • ndc11
    0527512582
    1892 mL in 1 BOTTLE (0527-5125-82)

Annotations

UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A075993
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": "0527-5125_1b869904-b3c5-4f81-a333-1f26b6b2c7bf",
  "productndc": "0527-5125",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "075993",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10GM/15ML",
        "product_no": "001",
        "approval_date": "Jul 26, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACTULOSE",
  "proprietary_name": "LACTULOSE",
  "active_ingred_unit": "g/15mL",
  "application_number": "ANDA075993",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LACTULOSE",
  "start_marketing_date": "20010726",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code A06AD11.

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