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United States · US · US:58602-702_94169799-0508-439b-93c5-132b9e6ae767

Loratadine

Orange BookUNIISPLATC R06AX13

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

Identification

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

Packs · 20

  • ndc11
    5860270204
    10 BLISTER PACK in 1 CARTON (58602-702-04) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5860270205
    5 BLISTER PACK in 1 CARTON (58602-702-05) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5860270209
    1 BOTTLE in 1 CARTON (58602-702-09) / 30 TABLET in 1 BOTTLE
  • ndc11
    5860270215
    1 BOTTLE in 1 CARTON (58602-702-15) / 60 TABLET in 1 BOTTLE
  • ndc11
    5860270217
    1 BOTTLE in 1 CARTON (58602-702-17) / 45 TABLET in 1 BOTTLE
  • ndc11
    5860270219
    1 BOTTLE in 1 CARTON (58602-702-19) / 90 TABLET in 1 BOTTLE
  • ndc11
    5860270221
    1 BOTTLE in 1 CARTON (58602-702-21) / 100 TABLET in 1 BOTTLE
  • ndc11
    5860270223
    1 BOTTLE in 1 CARTON (58602-702-23) / 120 TABLET in 1 BOTTLE
  • ndc11
    5860270229
    1 BOTTLE in 1 CARTON (58602-702-29) / 150 TABLET in 1 BOTTLE
  • ndc11
    5860270232
    1 BOTTLE in 1 CARTON (58602-702-32) / 180 TABLET in 1 BOTTLE
  • ndc11
    5860270238
    1 BOTTLE in 1 CARTON (58602-702-38) / 300 TABLET in 1 BOTTLE
  • ndc11
    5860270239
    1 BOTTLE in 1 CARTON (58602-702-39) / 365 TABLET in 1 BOTTLE
  • ndc11
    5860270240
    1 BOTTLE in 1 CARTON (58602-702-40) / 500 TABLET in 1 BOTTLE
  • ndc11
    5860270244
    1 BOTTLE in 1 CARTON (58602-702-44) / 400 TABLET in 1 BOTTLE
  • ndc11
    5860270254
    1 BOTTLE in 1 CARTON (58602-702-54) / 70 TABLET in 1 BOTTLE
  • ndc11
    5860270260
    1 BLISTER PACK in 1 CARTON (58602-702-60) / 5 TABLET in 1 BLISTER PACK
  • ndc11
    5860270267
    2 BLISTER PACK in 1 CARTON (58602-702-67) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5860270281
    1 BOTTLE in 1 CARTON (58602-702-81) / 108 TABLET in 1 BOTTLE
  • ndc11
    5860270283
    1 BLISTER PACK in 1 CARTON (58602-702-83) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5860270284
    3 BLISTER PACK in 1 CARTON (58602-702-84) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A208314
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": "58602-702_94169799-0508-439b-93c5-132b9e6ae767",
  "productndc": "58602-702",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208314",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Apr 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208314",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20180416",
  "active_numerator_strength": "10"
}

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