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United States · US · US:71610-848_35bc5d7a-4115-4fd4-e063-6394a90a4f20
Zolpidem
Orange BookUNIISPLATC N05CF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeN05CF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 11
- ndc11716108481010 TABLET in 1 BOTTLE (71610-848-10)
- ndc11716108481414 TABLET in 1 BOTTLE (71610-848-14)
- ndc11716108481515 TABLET in 1 BOTTLE (71610-848-15)
- ndc11716108482020 TABLET in 1 BOTTLE (71610-848-20)
- ndc11716108482121 TABLET in 1 BOTTLE (71610-848-21)
- ndc11716108482525 TABLET in 1 BOTTLE (71610-848-25)
- ndc11716108482828 TABLET in 1 BOTTLE (71610-848-28)
- ndc11716108483030 TABLET in 1 BOTTLE (71610-848-30)
- ndc11716108484545 TABLET in 1 BOTTLE (71610-848-45)
- ndc11716108485360 TABLET in 1 BOTTLE (71610-848-53)
- ndc11716108486090 TABLET in 1 BOTTLE (71610-848-60)
Annotations
UNII (FDA Substance ID)
WY6W63843K
ZOLPIDEM TARTRATE
RxCUI 221183
Orange Book
A077214
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": "71610-848_35bc5d7a-4115-4fd4-e063-6394a90a4f20",
"productndc": "71610-848",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077214",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Apr 23, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Apr 23, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZOLPIDEM TARTRATE",
"proprietary_name": "Zolpidem",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077214",
"marketing_category": "ANDA",
"nonproprietary_name": "Zolpidem Tartrate",
"start_marketing_date": "20070423",
"active_numerator_strength": "10"
}Related drugs
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