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United States · US · US:16729-132_438fdf1f-3027-fb5a-e063-6294a90ac8d4
QUETIAPINE FUMARATE
Orange BookUNIISPLATC N05AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeN05AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11167291321260 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-132-12)
Annotations
UNII (FDA Substance ID)
2S3PL1B6UJ
QUETIAPINE FUMARATE
RxCUI 221153
Orange Book
A206252
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2S3PL1B6UJ",
"rxcui": "221153",
"inchikey": "ZTHJULTYCAQOIJ-WXXKFALUSA-N",
"display_name": "QUETIAPINE FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"16f48034-b8c9-ab2b-e063-6294a90adf65": {
"match": "brand_token",
"title": "QUETIAPINE FUMARATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]",
"spl_version": "2",
"published_date": "2026-06-01"
}
},
"productid": "16729-132_438fdf1f-3027-fb5a-e063-6294a90ac8d4",
"productndc": "16729-132",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "206252",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Nov 29, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "QUETIAPINE FUMARATE",
"proprietary_name": "QUETIAPINE FUMARATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206252",
"marketing_category": "ANDA",
"nonproprietary_name": "QUETIAPINE FUMARATE",
"start_marketing_date": "20171130",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05AH04.
- CAACH-QUETIAPINEACCORD HEALTHCARE INC
- CAACH-QUETIAPINEACCORD HEALTHCARE INC
- CAACH-QUETIAPINEACCORD HEALTHCARE INC
- CAACH-QUETIAPINEACCORD HEALTHCARE INC
- CAACH-QUETIAPINEACCORD HEALTHCARE INC
- CAACH-QUETIAPINE FUMARATE XRACCORD HEALTHCARE INC
- CAACH-QUETIAPINE FUMARATE XRACCORD HEALTHCARE INC
- CAACH-QUETIAPINE FUMARATE XRACCORD HEALTHCARE INC
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