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United States · US · US:21130-128_eb0dd73c-7d2d-424f-a939-dcdb18ee21f1
Signature Care Omeprazole
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSafeway
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1121130128553 CARTON in 1 CARTON (21130-128-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
- ndc11211301287414 BLISTER PACK in 1 CARTON (21130-128-74) / 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": {
"4f555b8f-5193-e685-e063-6294a90a7ba2": {
"match": "brand_token",
"title": "SIGNATURE PAIN RELIEF CREAM (4% LIDOCAINE) CREAM [SHENGNAN (GUANGZHOU) COSMETICS CO., LTD]",
"spl_version": "1",
"published_date": "2026-04-14"
}
},
"productid": "21130-128_eb0dd73c-7d2d-424f-a939-dcdb18ee21f1",
"productndc": "21130-128",
"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": "Signature Care Omeprazole",
"active_ingred_unit": "mg/1",
"application_number": "NDA209400",
"marketing_category": "NDA",
"nonproprietary_name": "omeprazole",
"start_marketing_date": "20180711",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC01.
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