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
6318770715
15 TABLET, FILM COATED in 1 BOTTLE (63187-707-15)
ndc11
6318770730
30 TABLET, FILM COATED in 1 BOTTLE (63187-707-30)
ndc11
6318770760
60 TABLET, FILM COATED in 1 BOTTLE (63187-707-60)
ndc11
6318770790
90 TABLET, FILM COATED in 1 BOTTLE (63187-707-90)

Annotations

UNII (FDA Substance ID)

WY6W63843K

ZOLPIDEM TARTRATE

RxCUI 221183

Orange Book

A076410

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": "63187-707_f8dfb619-9219-4973-9362-f6a32ecac185",
  "productndc": "63187-707",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076410",
    "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 Tartrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076410",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zolpidem Tartrate",
  "start_marketing_date": "20070423",
  "active_numerator_strength": "5"
}

Related drugs

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