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United States · US · US:83745-405_b0b2ff56-185f-4e6e-9519-14af29f765e8

Lactulose

Orange BookUNIISPLATC A06AD11

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

Identification

ManufacturerAPOZEAL PHARMACEUTICALS INC
CountryUS (United States)
ATC codeA06AD11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8374540508
    237 mL in 1 BOTTLE (83745-405-08)
  • ndc11
    8374540516
    473 mL in 1 BOTTLE (83745-405-16)
  • ndc11
    8374540532
    946 mL in 1 BOTTLE (83745-405-32)

Annotations

UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A207786
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": "83745-405_b0b2ff56-185f-4e6e-9519-14af29f765e8",
  "productndc": "83745-405",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "207786",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10GM/15ML",
        "product_no": "001",
        "approval_date": "Jun 11, 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": "ANDA207786",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lactulose",
  "start_marketing_date": "20241220",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code A06AD11.

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