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United States · US · US:63187-170_145db374-f2b5-40e4-8801-435b802c9b77
Omeprazole
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11631871703030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-170-30)
- ndc11631871706060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-170-60)
- ndc11631871709090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-170-90)
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A076048
ABABAB
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": {
"b3ec4a44-5643-4438-b41b-e04946436719": {
"match": "brand_token",
"title": "OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY]",
"spl_version": "3",
"published_date": "2026-05-29"
}
},
"productid": "63187-170_145db374-f2b5-40e4-8801-435b802c9b77",
"productndc": "63187-170",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "076048",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Oct 22, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Oct 22, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "003",
"approval_date": "Jan 21, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OMEPRAZOLE",
"shortage_reason": "Omeprazole Delayed Release Capsule",
"shortage_status": "current",
"proprietary_name": "Omeprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076048",
"marketing_category": "ANDA",
"nonproprietary_name": "Omeprazole",
"start_marketing_date": "20090121",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BC01.
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