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United States · US · US:55111-643_8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d
Omeprazole
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc115511164301100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-643-01)
- ndc115511164305500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-643-05)
- ndc11551116433030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-643-30)
- ndc11551116437810 BLISTER PACK in 1 CARTON (55111-643-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-643-79)
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A078490
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": "55111-643_8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d",
"productndc": "55111-643",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "078490",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "001",
"approval_date": "Apr 17, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Mar 16, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "Mar 16, 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": "ANDA078490",
"marketing_category": "ANDA",
"nonproprietary_name": "Omeprazole",
"start_marketing_date": "20140301",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A02BC01.
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