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United States · US · US:65628-272_461e360d-0e63-e7b5-e063-6294a90a17c8
Konvomep
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1165628272031 KIT in 1 CARTON (65628-272-03) * 150 mL in 1 BOTTLE (65628-270-05) * 300 mL in 1 BOTTLE (65628-270-10) * 150 mL in 1 BOTTLE (65628-271-05) * 300 mL in 1 BOTTLE (65628-271-10) * 90 mL in 1 BOTTLE (65628-271-03) * 90 mL in 1 BOTTLE (65628-270-03)
- ndc1165628272051 KIT in 1 CARTON (65628-272-05) * 150 mL in 1 BOTTLE (65628-270-05) * 300 mL in 1 BOTTLE (65628-270-10) * 150 mL in 1 BOTTLE (65628-271-05) * 300 mL in 1 BOTTLE (65628-271-10) * 90 mL in 1 BOTTLE (65628-271-03) * 90 mL in 1 BOTTLE (65628-270-03)
- ndc1165628272101 KIT in 1 CARTON (65628-272-10) * 150 mL in 1 BOTTLE (65628-270-05) * 300 mL in 1 BOTTLE (65628-270-10) * 150 mL in 1 BOTTLE (65628-271-05) * 300 mL in 1 BOTTLE (65628-271-10) * 90 mL in 1 BOTTLE (65628-271-03) * 90 mL in 1 BOTTLE (65628-270-03)
Annotations
Orange Book
N213593
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"688ed6f1-d78a-4006-a682-57021cb38a3e": {
"match": "brand_token",
"title": "KONVOMEP (OMEPRAZOLE AND SODIUM BICARBONATE) KIT [AZURITY PHARMACEUTICALS, INC.]",
"spl_version": "6",
"published_date": "2025-12-18"
}
},
"productid": "65628-272_461e360d-0e63-e7b5-e063-6294a90a17c8",
"productndc": "65628-272",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "213593",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2MG/ML;84MG/ML",
"product_no": "001",
"approval_date": "Aug 30, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Konvomep",
"active_ingred_unit": null,
"application_number": "NDA213593",
"marketing_category": "NDA",
"nonproprietary_name": "omeprazole and sodium bicarbonate",
"start_marketing_date": "20230215",
"active_numerator_strength": null
}Access this data programmatically
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