Zolpidem Tartrate

Orange BookUNIISPLATC N05CF02

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN05CF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4733530713
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-13)
ndc11
4733530788
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-88)

Annotations

UNII (FDA Substance ID)

WY6W63843K

ZOLPIDEM TARTRATE

RxCUI 221183

Orange Book

A204170

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": "47335-307_4a5c474b-e752-4d01-be37-a66e7c9bf62e",
  "productndc": "47335-307",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204170",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6.25MG",
        "product_no": "001",
        "approval_date": "Jan 24, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "002",
        "approval_date": "Jan 24, 2017"
      }
    ],
    "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": "ANDA204170",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zolpidem Tartrate",
  "start_marketing_date": "20170515",
  "active_numerator_strength": "6.25"
}

Related drugs

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