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United States · US · US:63629-4597_56db3e80-5b7e-4611-92c7-88ed80f4e657
Zolpidem tartrate
Orange BookUNIISPLATC N05CF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN05CF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11636294597130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-1)
- ndc11636294597260 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-2)
- ndc11636294597328 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-3)
- ndc1163629459748 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-4)
- ndc11636294597518 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-5)
- ndc11636294597690 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-6)
Annotations
UNII (FDA Substance ID)
WY6W63843K
ZOLPIDEM TARTRATE
RxCUI 221183
Orange Book
A090107
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WY6W63843K",
"rxcui": "221183",
"inchikey": "VXRDAMSNTXUHFX-CEAXSRTFSA-N",
"display_name": "ZOLPIDEM TARTRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b49f6c18-e155-4728-a79a-9354e8c3c8f4": {
"match": "brand_token",
"title": "ZOLPIDEM TARTRATE CAPSULE [UMEDICA LABORATORIES USA INC.]",
"spl_version": "2",
"published_date": "2026-05-27"
}
},
"productid": "63629-4597_56db3e80-5b7e-4611-92c7-88ed80f4e657",
"productndc": "63629-4597",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "090107",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "6.25MG",
"product_no": "001",
"approval_date": "Jul 1, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "12.5MG",
"product_no": "002",
"approval_date": "Jul 1, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZOLPIDEM TARTRATE",
"proprietary_name": "Zolpidem tartrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090107",
"marketing_category": "ANDA",
"nonproprietary_name": "Zolpidem tartrate",
"start_marketing_date": "20111031",
"active_numerator_strength": "12.5"
}Related drugs
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