ZOLPIDEM TARTRATE

Orange BookUNIISPLATC N05CF02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN05CF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6318756515
15 TABLET in 1 BOTTLE (63187-565-15)
ndc11
6318756530
30 TABLET in 1 BOTTLE (63187-565-30)
ndc11
6318756560
60 TABLET in 1 BOTTLE (63187-565-60)
ndc11
6318756590
90 TABLET in 1 BOTTLE (63187-565-90)

Annotations

UNII (FDA Substance ID)

WY6W63843K

ZOLPIDEM TARTRATE

RxCUI 221183

Orange Book

A077903

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": "63187-565_ae552b3d-c4e7-4abb-9132-0ffc2b477567",
  "productndc": "63187-565",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077903",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 17, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Aug 17, 2007"
      }
    ],
    "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": "ANDA077903",
  "marketing_category": "ANDA",
  "nonproprietary_name": "zolpidem tartrate",
  "start_marketing_date": "20070905",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N05CF02.

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