🇺🇸
United States · US · US:43598-307_dc9f1708-68a6-cb89-36c5-4e5fdb30100e
Omeprazole and Sodium Bicarbonate
Orange BookUNIISPLATC A02BC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc.,
CountryUS (United States)
ATC codeA02BC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1143598307011 PACKET in 1 CARTON (43598-307-01) / 1 POWDER, FOR SUSPENSION in 1 PACKET
- ndc11435983071414 PACKET in 1 CARTON (43598-307-14) / 1 POWDER, FOR SUSPENSION in 1 PACKET
- ndc11435983072828 PACKET in 1 CARTON (43598-307-28) / 1 POWDER, FOR SUSPENSION in 1 PACKET
- ndc11435983074242 PACKET in 1 CARTON (43598-307-42) / 1 POWDER, FOR SUSPENSION in 1 PACKET
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A217784
DailyMed SPL labels
1 version tracked
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": "43598-307_dc9f1708-68a6-cb89-36c5-4e5fdb30100e",
"productndc": "43598-307",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "217784",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "20MG/PACKET;1.68GM/PACKET",
"product_no": "001",
"approval_date": "May 9, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "OMEPRAZOLE; SODIUM BICARBONATE",
"proprietary_name": "Omeprazole and Sodium Bicarbonate",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA217784",
"marketing_category": "ANDA",
"nonproprietary_name": "Omeprazole and Sodium Bicarbonate",
"start_marketing_date": "20240715",
"active_numerator_strength": "20; 1680"
}Related drugs
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