🇺🇸
United States · US · US:41520-939_c40594a4-de5f-4267-bbe2-e07722d633e6
careone omeprazole
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Sales Company
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1141520939553 CARTON in 1 CARTON (41520-939-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
- ndc11415209397414 BLISTER PACK in 1 CARTON (41520-939-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
N209400
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Omeprazole Delayed Release Capsule
Raw payload (JSON)
{
"unii": {
"unii": "KG60484QX9",
"rxcui": "7646",
"inchikey": "SUBDBMMJDZJVOS-UHFFFAOYSA-N",
"display_name": "OMEPRAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"206f5483-7de1-4bc3-af27-190e211bcb95": {
"match": "brand_token",
"title": "CAREONE ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [AMERICAN SALES COMPANY]",
"spl_version": "9",
"published_date": "2026-05-25"
}
},
"productid": "41520-939_c40594a4-de5f-4267-bbe2-e07722d633e6",
"productndc": "41520-939",
"dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
"orange_book": {
"appl_no": "209400",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG",
"product_no": "001",
"approval_date": "Jul 5, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "OMEPRAZOLE",
"shortage_reason": "Omeprazole Delayed Release Capsule",
"shortage_status": "current",
"proprietary_name": "careone omeprazole",
"active_ingred_unit": "mg/1",
"application_number": "NDA209400",
"marketing_category": "NDA",
"nonproprietary_name": "omeprazole",
"start_marketing_date": "20180302",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC01.
Access this data programmatically
Query careone omeprazole and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.