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United States · US · US:76420-330_359e8af9-0b81-5837-e063-6394a90a58a1

Loratadine Allergy Relief

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7642033001
    100 TABLET in 1 BOTTLE (76420-330-01)
  • ndc11
    7642033003
    300 TABLET in 1 BOTTLE (76420-330-03)
  • ndc11
    7642033005
    500 TABLET in 1 BOTTLE (76420-330-05)
  • ndc11
    7642033010
    10 TABLET in 1 BOTTLE (76420-330-10)
  • ndc11
    7642033011
    10 TABLET in 1 BLISTER PACK (76420-330-11)
  • ndc11
    7642033020
    20 TABLET in 1 BOTTLE (76420-330-20)
  • ndc11
    7642033030
    30 TABLET in 1 BOTTLE (76420-330-30)
  • ndc11
    7642033031
    30 TABLET in 1 BLISTER PACK (76420-330-31)
  • ndc11
    7642033060
    60 TABLET in 1 BOTTLE (76420-330-60)
  • ndc11
    7642033090
    90 TABLET in 1 BOTTLE (76420-330-90)

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076134
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": "76420-330_359e8af9-0b81-5837-e063-6394a90a58a1",
  "productndc": "76420-330",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076134",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 18, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076134",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20171101",
  "active_numerator_strength": "10"
}

Related drugs

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