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United States · US · US:62135-892_1d600b06-58c7-b83e-e063-6294a90a86f9

Generlac

Orange BookUNIISPLATC A06AD11

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

Identification

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

Packs · 2

  • ndc11
    6213589247
    473 mL in 1 BOTTLE (62135-892-47)
  • ndc11
    6213589294
    946 mL in 1 BOTTLE (62135-892-94)

Annotations

UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A074603
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": {
    "35207edd-a5fe-4369-a079-7a8b0d2f2e91": {
      "match": "brand_token",
      "title": "GENERLAC (LACTULOSE) SOLUTION [CHARTWELL RX, LLC]",
      "spl_version": "1",
      "published_date": "2024-07-18"
    }
  },
  "productid": "62135-892_1d600b06-58c7-b83e-e063-6294a90a86f9",
  "productndc": "62135-892",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "074603",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10GM/15ML",
        "product_no": "001",
        "approval_date": "Oct 31, 1996"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACTULOSE",
  "proprietary_name": "Generlac",
  "active_ingred_unit": "g/15mL",
  "application_number": "ANDA074603",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lactulose",
  "start_marketing_date": "19961031",
  "active_numerator_strength": "10"
}

Related drugs

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