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United States · US · US:0378-2085_bd08545b-3f1d-44c5-bdd9-05acd7f69a0a
Dexlansoprazole
Orange BookUNIISPLATC A02BC06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA02BC06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11037820859330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2085-93)
Annotations
UNII (FDA Substance ID)
HS2S9VK3NH
DEXLANSOPRAZOLE SESQUIHYDRATE
Orange Book
A205205
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "HS2S9VK3NH",
"rxcui": null,
"inchikey": "XTQWZVSRVXCIGB-BBBDYAHLSA-N",
"display_name": "DEXLANSOPRAZOLE SESQUIHYDRATE",
"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": "0378-2085_bd08545b-3f1d-44c5-bdd9-05acd7f69a0a",
"productndc": "0378-2085",
"dosage_form": "CAPSULE, DELAYED RELEASE PELLETS",
"orange_book": {
"appl_no": "205205",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "001",
"approval_date": "Jan 19, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "60MG",
"product_no": "002",
"approval_date": "Jan 19, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXLANSOPRAZOLE SESQUIHYDRATE",
"proprietary_name": "Dexlansoprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205205",
"marketing_category": "ANDA",
"nonproprietary_name": "dexlansoprazole",
"start_marketing_date": "20240122",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code A02BC06.
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