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United States · US · US:68788-4016_836f566c-0296-408a-ad2a-6a77e1855218

Allergy relief

Orange BookUNIISPLATC R06AX13

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

Identification

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

Packs · 6

  • ndc11
    6878840160
    10 TABLET in 1 BOTTLE (68788-4016-0)
  • ndc11
    6878840161
    14 TABLET in 1 BOTTLE (68788-4016-1)
  • ndc11
    6878840163
    30 TABLET in 1 BOTTLE (68788-4016-3)
  • ndc11
    6878840165
    15 TABLET in 1 BOTTLE (68788-4016-5)
  • ndc11
    6878840166
    60 TABLET in 1 BOTTLE (68788-4016-6)
  • ndc11
    6878840169
    90 TABLET in 1 BOTTLE (68788-4016-9)

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A075209
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": {
    "934c7b91-3cba-47f0-8efa-77216f3f15c4": {
      "match": "brand_token",
      "title": "ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [AMERISOURCE BERGEN]",
      "spl_version": "14",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68788-4016_836f566c-0296-408a-ad2a-6a77e1855218",
  "productndc": "68788-4016",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075209",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jan 21, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Allergy relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075209",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20250829",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AX13.

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