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United States · US · US:49884-148_d173ea78-6398-49ea-8742-5d4093250cfd
Dexlansoprazole
Orange BookUNIISPLATC A02BC06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeA02BC06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11498841480990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-09)
- ndc11498841481130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-11)
Annotations
UNII (FDA Substance ID)
UYE4T5I70X
DEXLANSOPRAZOLE
RxCUI 816346
Orange Book
A202294
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "UYE4T5I70X",
"rxcui": "816346",
"inchikey": "MJIHNNLFOKEZEW-RUZDIDTESA-N",
"display_name": "DEXLANSOPRAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"8dca4887-c75a-4021-8564-b704e9e1fa3e": {
"match": "brand_token",
"title": "DEXLANSOPRAZOLE DELAYED RELEASE (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, LLC]",
"spl_version": "9",
"published_date": "2026-06-02"
}
},
"productid": "49884-148_d173ea78-6398-49ea-8742-5d4093250cfd",
"productndc": "49884-148",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "202294",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "60MG",
"product_no": "001",
"approval_date": "Apr 19, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "002",
"approval_date": "Jun 16, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXLANSOPRAZOLE",
"proprietary_name": "Dexlansoprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202294",
"marketing_category": "ANDA",
"nonproprietary_name": "Dexlansoprazole",
"start_marketing_date": "20221122",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code A02BC06.
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