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United States · US · US:66220-719_85528d56-e38f-4565-9136-c7639b479634

KRISTALOSE

Orange BookUNIIATC A06AD11

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

Identification

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

Packs · 1

  • ndc11
    6622071930
    30 POUCH in 1 CARTON (66220-719-30) / 10 g in 1 POUCH (66220-719-01)

Annotations

UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A074712
AAAA
Raw payload (JSON)
{
  "unii": {
    "unii": "9U7D5QH5AE",
    "rxcui": "6218",
    "inchikey": "PFCRQPBOOFTZGQ-VZXVHDRGSA-N",
    "display_name": "LACTULOSE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "66220-719_85528d56-e38f-4565-9136-c7639b479634",
  "productndc": "66220-719",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "074712",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "10GM/PACKET",
        "product_no": "001",
        "approval_date": "Dec 10, 1997"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "20GM/PACKET",
        "product_no": "002",
        "approval_date": "Dec 10, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACTULOSE",
  "proprietary_name": "KRISTALOSE",
  "active_ingred_unit": "g/10g",
  "application_number": "ANDA074712",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lactulose",
  "start_marketing_date": "20120120",
  "active_numerator_strength": "10"
}

Related drugs

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