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United States · US · US:49348-636_29a2cbbe-88da-1498-e063-6394a90ac36c

Sunmark

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerStrategic Sourcing Services LLC
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4934863634
    1 BOTTLE in 1 CARTON (49348-636-34) / 120 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076805
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7AJO3BO7QN",
    "rxcui": "28889",
    "inchikey": "JCCNYMKQOSZNPW-UHFFFAOYSA-N",
    "display_name": "LORATADINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "06720229-7d58-499e-b7de-cb4bda5ae416": {
      "match": "brand_token",
      "title": "SUNMARK SALINE SINGLE LAXATIVE (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [STRATEGIC SOURCING SERVICES LLC]",
      "spl_version": "5",
      "published_date": "2026-01-12"
    }
  },
  "productid": "49348-636_29a2cbbe-88da-1498-e063-6394a90ac36c",
  "productndc": "49348-636",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "076805",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Aug 20, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Sunmark",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA076805",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20040820",
  "active_numerator_strength": "5"
}

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