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United States · US · US:11523-0102_4526d9ef-02fb-338e-e063-6394a90af108
Claritin-D
Orange BookUNIISPLATC R06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare LLC.
CountryUS (United States)
ATC codeR06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1111523010211 BLISTER PACK in 1 CARTON (11523-0102-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1111523010221 BLISTER PACK in 1 CARTON (11523-0102-2) / 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A075706
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": {
"f046a807-ab8c-0620-e053-2a95a90a9d3c": {
"match": "brand_token",
"title": "CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [BAYER HEALTHCARE LLC.]",
"spl_version": "11",
"published_date": "2025-12-08"
}
},
"productid": "11523-0102_4526d9ef-02fb-338e-e063-6394a90af108",
"productndc": "11523-0102",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075706",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG;240MG",
"product_no": "001",
"approval_date": "Feb 21, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
"proprietary_name": "Claritin-D",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA075706",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine pseudoephedrine sulfate",
"start_marketing_date": "20221212",
"active_numerator_strength": "10; 240"
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