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United States · US · US:61037-471_f0b79991-a87f-2b4b-e053-2995a90a8690

Lactulose Solution

Orange BookUNIISPLATC A06AD11

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

Identification

ManufacturerBajaj Medical, LLC
CountryUS (United States)
ATC codeA06AD11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    6103747102
    236 mL in 1 BOTTLE (61037-471-02)
  • ndc11
    6103747103
    946 mL in 1 BOTTLE (61037-471-03)
  • ndc11
    6103747104
    1893 mL in 1 JUG (61037-471-04)
  • ndc11
    6103747105
    15 mL in 1 CUP, UNIT-DOSE (61037-471-05)
  • ndc11
    6103747106
    3785 mL in 1 JUG (61037-471-06)
  • ndc11
    6103747112
    473 mL in 1 BOTTLE (61037-471-12)
  • ndc11
    6103747113
    118 mL in 1 BOTTLE (61037-471-13)
  • ndc11
    6103747114
    30 mL in 1 CUP, UNIT-DOSE (61037-471-14)

Annotations

UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A076645
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; RECTAL",
  "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": "61037-471_f0b79991-a87f-2b4b-e053-2995a90a8690",
  "productndc": "61037-471",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "076645",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10GM/15ML",
        "product_no": "001",
        "approval_date": "Jul 28, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACTULOSE",
  "proprietary_name": "Lactulose Solution",
  "active_ingred_unit": "g/15mL",
  "application_number": "ANDA076645",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lactulose Solution USP, 10 g/15 mL",
  "start_marketing_date": "20211014",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code A06AD11.

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