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United States · US · US:25000-021_adf6c78c-edb1-4ffb-a934-d8cb772e621f
Loratadine
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc112500002108100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-08)
- ndc112500002113600 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-13)
- ndc1125000021214 BAG in 1 BOX (25000-021-21) / 7500 CAPSULE, LIQUID FILLED in 1 BAG
- ndc11250000213428 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (25000-021-34)
- ndc1125000021363 BLISTER PACK in 1 CARTON (25000-021-36) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- ndc1125000021468 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-46)
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A206214
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": "25000-021_adf6c78c-edb1-4ffb-a934-d8cb772e621f",
"productndc": "25000-021",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "206214",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Sep 23, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Loratadine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206214",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine",
"start_marketing_date": "20161001",
"active_numerator_strength": "10"
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