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United States · US · US:51316-502_28e49606-cbf6-7029-e063-6394a90ae3b7
LORATADINE
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCVS PHARMACY, INC
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1151316502011 BLISTER PACK in 1 CARTON (51316-502-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
- ndc1151316502022 BLISTER PACK in 1 CARTON (51316-502-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
- ndc1151316502033 BLISTER PACK in 1 CARTON (51316-502-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
- ndc1151316502044 BLISTER PACK in 1 CARTON (51316-502-04) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
- ndc1151316502055 BLISTER PACK in 1 CARTON (51316-502-05) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
- ndc1151316502066 BLISTER PACK in 1 CARTON (51316-502-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A212795
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": "51316-502_28e49606-cbf6-7029-e063-6394a90ae3b7",
"productndc": "51316-502",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "212795",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Sep 18, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "LORATADINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212795",
"marketing_category": "ANDA",
"nonproprietary_name": "LORATADINE",
"start_marketing_date": "20211231",
"active_numerator_strength": "5"
}Related drugs
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