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United States · US · US:0116-4005_4f6f0368-4b59-a9df-e063-6294a90ae43c

Lactulose

Orange BookUNIISPLATC A06AD11

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

Identification

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

Packs · 7

  • ndc11
    0116400508
    237 mL in 1 BOTTLE (0116-4005-08)
  • ndc11
    0116400510
    100 CASE in 1 CASE (0116-4005-10) / 40 TRAY in 1 CASE (0116-4005-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15)
  • ndc11
    0116400511
    100 CASE in 1 CASE (0116-4005-11) / 40 TRAY in 1 CASE (0116-4005-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30)
  • ndc11
    0116400515
    15 mL in 1 CUP, UNIT-DOSE (0116-4005-15)
  • ndc11
    0116400516
    473 mL in 1 BOTTLE (0116-4005-16)
  • ndc11
    0116400530
    30 mL in 1 CUP, UNIT-DOSE (0116-4005-30)
  • ndc11
    0116400532
    946 mL in 1 BOTTLE (0116-4005-32)

Annotations

UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A075911
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": "0116-4005_4f6f0368-4b59-a9df-e063-6294a90ae43c",
  "productndc": "0116-4005",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "075911",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10GM/15ML",
        "product_no": "001",
        "approval_date": "Feb 21, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACTULOSE",
  "proprietary_name": "Lactulose",
  "active_ingred_unit": "g/15mL",
  "application_number": "ANDA075911",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lactulose",
  "start_marketing_date": "20220701",
  "active_numerator_strength": "10"
}

Related drugs

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