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United States · US · US:43598-756_33224371-b336-2c1e-63dd-7a8ce9d195ff
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
- ndc1143598756101 BLISTER PACK in 1 CARTON (43598-756-10) / 10 TABLET in 1 BLISTER PACK
- ndc1143598756303 BLISTER PACK in 1 CARTON (43598-756-30) / 10 TABLET 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": "43598-756_33224371-b336-2c1e-63dd-7a8ce9d195ff",
"productndc": "43598-756",
"dosage_form": "TABLET",
"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": "20210519",
"active_numerator_strength": "5"
}Related drugs
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