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United States · US · US:68083-493_6cd73b63-72e7-4f03-955d-fa897f905c2a
Pantoprazole sodium
Orange BookUNIISPLATC A02BC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeA02BC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1168083493011 VIAL in 1 CARTON (68083-493-01) / 10 mL in 1 VIAL
- ndc11680834931010 CARTON in 1 PACKAGE (68083-493-10) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL
- ndc11680834932525 CARTON in 1 PACKAGE (68083-493-25) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
6871619Q5X
PANTOPRAZOLE SODIUM
RxCUI 236632
Orange Book
A204400
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6871619Q5X",
"rxcui": "236632",
"inchikey": "VNKNFEINTHUQGZ-UHFFFAOYSA-N",
"display_name": "PANTOPRAZOLE SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"52bbab54-9f11-77bc-e063-6394a90ab449": {
"match": "brand_token",
"title": "PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [COUPLER LLC]",
"spl_version": "1",
"published_date": "2026-05-28"
}
},
"productid": "68083-493_6cd73b63-72e7-4f03-955d-fa897f905c2a",
"productndc": "68083-493",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "204400",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 40MG BASE/VIAL",
"product_no": "001",
"approval_date": "May 18, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PANTOPRAZOLE SODIUM",
"proprietary_name": "Pantoprazole sodium",
"active_ingred_unit": "mg/10mL",
"application_number": "ANDA204400",
"marketing_category": "ANDA",
"nonproprietary_name": "Pantoprazole sodium",
"start_marketing_date": "20220518",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BC02.
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