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United States · US · US:46708-824_24c33ba6-bf47-434e-903e-f7ced98e030e
Dexlansoprazole
Orange BookUNIISPLATC A02BC06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeA02BC06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11467088243030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-824-30)
- ndc11467088249090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-824-90)
Annotations
UNII (FDA Substance ID)
UYE4T5I70X
DEXLANSOPRAZOLE
RxCUI 816346
Orange Book
A219115
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": "46708-824_24c33ba6-bf47-434e-903e-f7ced98e030e",
"productndc": "46708-824",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "219115",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "001",
"approval_date": "Nov 12, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "60MG",
"product_no": "002",
"approval_date": "Nov 12, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXLANSOPRAZOLE",
"proprietary_name": "Dexlansoprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219115",
"marketing_category": "ANDA",
"nonproprietary_name": "Dexlansoprazole",
"start_marketing_date": "20251114",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code A02BC06.
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