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United States · US · US:43598-758_2f67bf36-2053-dd83-afad-a64810fa9050
LORATADINE
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1143598758101 BLISTER PACK in 1 CARTON (43598-758-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
- ndc1143598758303 BLISTER PACK in 1 CARTON (43598-758-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A213294
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": "43598-758_2f67bf36-2053-dd83-afad-a64810fa9050",
"productndc": "43598-758",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "213294",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Oct 30, 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": "ANDA213294",
"marketing_category": "ANDA",
"nonproprietary_name": "LORATADINE",
"start_marketing_date": "20210519",
"active_numerator_strength": "10"
}Related drugs
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