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United States · US · US:62332-147_64d45e8d-158b-42f2-84aa-14fc849eaf0e
alcaftadine
Orange BookUNIISPLATC S01GX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeS01GX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1162332147031 BOTTLE in 1 CARTON (62332-147-03) / 3 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
7Z8O94ECSX
ALCAFTADINE
RxCUI 1000082
Orange Book
A209290
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7Z8O94ECSX",
"rxcui": "1000082",
"inchikey": "MWTBKTRZPHJQLH-UHFFFAOYSA-N",
"display_name": "ALCAFTADINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"22473109-dc9e-45b6-b188-d7d5773f5a14": {
"match": "brand_token",
"title": "ALCAFTADINE SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.]",
"spl_version": "3",
"published_date": "2024-10-09"
}
},
"productid": "62332-147_64d45e8d-158b-42f2-84aa-14fc849eaf0e",
"productndc": "62332-147",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "209290",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.25%",
"product_no": "001",
"approval_date": "Oct 2, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ALCAFTADINE",
"proprietary_name": "alcaftadine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA209290",
"marketing_category": "ANDA",
"nonproprietary_name": "alcaftadine",
"start_marketing_date": "20241002",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code S01GX11.
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