🇺🇸
United States · US · US:80425-0430_1fa85237-6f77-fa21-e063-6294a90a1d75
Zolpidem
Orange BookUNIISPLATC N05CF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeN05CF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11804250430130 TABLET in 1 BOTTLE (80425-0430-1)
- ndc11804250430260 TABLET in 1 BOTTLE (80425-0430-2)
- ndc11804250430390 TABLET in 1 BOTTLE (80425-0430-3)
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": "80425-0430_1fa85237-6f77-fa21-e063-6294a90a1d75",
"productndc": "80425-0430",
"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": "20240813",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05CF02.
- CZADORMAAlkaloid - INT d.o.o., Ljubljana - Črnuče
- CZADORMAAlkaloid - INT d.o.o., Ljubljana - Črnuče
- CZADORMAAlkaloid - INT d.o.o., Ljubljana - Črnuče
- 🇺🇸AmbienSanofi-Aventis U.S. LLC
- 🇺🇸AmbienSanofi-Aventis U.S. LLC
- 🇺🇸AmbienCosette Pharmaceuticals, Inc.
- 🇺🇸AmbienCosette Pharmaceuticals, Inc.
- 🇺🇸AmbienCosette Pharmaceuticals, Inc.
Access this data programmatically
Query Zolpidem and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.