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United States · US · US:0121-1746_b73c2ddc-a690-46e1-aa89-40fa890c9ab4

LACTULOSE

Orange BookUNIISPLATC A06AD11

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

Identification

ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeA06AD11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0121174600
    10 TRAY in 1 CASE (0121-1746-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)
  • ndc11
    0121174606
    6 CARTON in 1 CASE (0121-1746-06) / 16 CUP, UNIT-DOSE in 1 CARTON / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)
  • ndc11
    0121174640
    4 TRAY in 1 CASE (0121-1746-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)

Annotations

UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A074623
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": "0121-1746_b73c2ddc-a690-46e1-aa89-40fa890c9ab4",
  "productndc": "0121-1746",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "074623",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "10GM/15ML",
        "product_no": "001",
        "approval_date": "Jul 30, 1996"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACTULOSE",
  "proprietary_name": "LACTULOSE",
  "active_ingred_unit": "g/30mL",
  "application_number": "ANDA074623",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LACTULOSE",
  "start_marketing_date": "20191203",
  "active_numerator_strength": "20"
}

Related drugs

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