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United States · US · US:71335-9684_dd311612-26be-4837-ab16-7be1e84fc397

Zolpidem

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 · 10

  • ndc11
    7133596840
    5 TABLET in 1 BOTTLE (71335-9684-0)
  • ndc11
    7133596841
    30 TABLET in 1 BOTTLE (71335-9684-1)
  • ndc11
    7133596842
    60 TABLET in 1 BOTTLE (71335-9684-2)
  • ndc11
    7133596843
    100 TABLET in 1 BOTTLE (71335-9684-3)
  • ndc11
    7133596844
    50 TABLET in 1 BOTTLE (71335-9684-4)
  • ndc11
    7133596845
    90 TABLET in 1 BOTTLE (71335-9684-5)
  • ndc11
    7133596846
    10 TABLET in 1 BOTTLE (71335-9684-6)
  • ndc11
    7133596847
    15 TABLET in 1 BOTTLE (71335-9684-7)
  • ndc11
    7133596848
    28 TABLET in 1 BOTTLE (71335-9684-8)
  • ndc11
    7133596849
    120 TABLET in 1 BOTTLE (71335-9684-9)

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": "71335-9684_dd311612-26be-4837-ab16-7be1e84fc397",
  "productndc": "71335-9684",
  "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": "20200924",
  "active_numerator_strength": "10"
}

Related drugs

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