Zolpidem Tartrate

Orange BookUNIISPLATC N05CF02

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

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
7133596290
25 TABLET, COATED in 1 BOTTLE (71335-9629-0)
ndc11
7133596291
30 TABLET, COATED in 1 BOTTLE (71335-9629-1)
ndc11
7133596292
60 TABLET, COATED in 1 BOTTLE (71335-9629-2)
ndc11
7133596293
10 TABLET, COATED in 1 BOTTLE (71335-9629-3)
ndc11
7133596294
100 TABLET, COATED in 1 BOTTLE (71335-9629-4)
ndc11
7133596295
20 TABLET, COATED in 1 BOTTLE (71335-9629-5)
ndc11
7133596296
90 TABLET, COATED in 1 BOTTLE (71335-9629-6)
ndc11
7133596297
56 TABLET, COATED in 1 BOTTLE (71335-9629-7)
ndc11
7133596298
28 TABLET, COATED in 1 BOTTLE (71335-9629-8)
ndc11
7133596299
120 TABLET, COATED in 1 BOTTLE (71335-9629-9)

Annotations

UNII (FDA Substance ID)

WY6W63843K

ZOLPIDEM TARTRATE

RxCUI 221183

Orange Book

A077322

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": "71335-9629_64b21e02-2a0c-4610-bd0b-18003214eaa8",
  "productndc": "71335-9629",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "077322",
    "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": "ANDA077322",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zolpidem Tartrate",
  "start_marketing_date": "20070423",
  "active_numerator_strength": "5"
}

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