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United States · US · US:68382-772_3de4f129-dc87-48e1-b934-b2a038df8cf7
LANSOPRAZOLE
Orange BookUNIISPLATC A02BC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA02BC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11683827727710 BLISTER PACK in 1 CARTON (68382-772-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-772-30)
Annotations
UNII (FDA Substance ID)
0K5C5T2QPG
LANSOPRAZOLE
RxCUI 17128
Orange Book
A200816
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0K5C5T2QPG",
"rxcui": "17128",
"inchikey": "MJIHNNLFOKEZEW-UHFFFAOYSA-N",
"display_name": "LANSOPRAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c9a43df0-efab-4486-860f-92afdb258c8b": {
"match": "brand_token",
"title": "LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [CARDINAL HEALTH 107, LLC]",
"spl_version": "5",
"published_date": "2026-06-01"
}
},
"productid": "68382-772_3de4f129-dc87-48e1-b934-b2a038df8cf7",
"productndc": "68382-772",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "200816",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "001",
"approval_date": "Nov 27, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "002",
"approval_date": "Nov 27, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LANSOPRAZOLE",
"proprietary_name": "LANSOPRAZOLE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA200816",
"marketing_category": "ANDA",
"nonproprietary_name": "LANSOPRAZOLE",
"start_marketing_date": "20181130",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code A02BC03.
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