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United States · US · US:49483-732_2c80ea14-8491-4d26-e063-6294a90aecf0

Loratadine 10 mg

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerTIME CAP LABORATORIES, INC.
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4948373265
    365 TABLET in 1 BOTTLE (49483-732-65)

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A219223
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": {
    "d778c4d2-184a-4dc8-9351-66d81d0618f2": {
      "match": "brand_token",
      "title": "LORATADINE TABLET [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "49483-732_2c80ea14-8491-4d26-e063-6294a90aecf0",
  "productndc": "49483-732",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219223",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 21, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine 10 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219223",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine Tablets USP, 10 mg",
  "start_marketing_date": "20250125",
  "active_numerator_strength": "10"
}

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