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United States · US · US:71335-0236_2a582cd7-cb01-4ec4-bd0a-d43dcd56c31c

zaleplon

Orange BookUNIISPLATC N05CF03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN05CF03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7133502361
    30 CAPSULE in 1 BOTTLE (71335-0236-1)
  • ndc11
    7133502362
    60 CAPSULE in 1 BOTTLE (71335-0236-2)
  • ndc11
    7133502363
    90 CAPSULE in 1 BOTTLE (71335-0236-3)
  • ndc11
    7133502364
    20 CAPSULE in 1 BOTTLE (71335-0236-4)
  • ndc11
    7133502365
    28 CAPSULE in 1 BOTTLE (71335-0236-5)

Annotations

UNII (FDA Substance ID)
S62U433RMH
ZALEPLON
RxCUI 74667
Orange Book
A078989
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "S62U433RMH",
    "rxcui": "74667",
    "inchikey": "HUNXMJYCHXQEGX-UHFFFAOYSA-N",
    "display_name": "ZALEPLON",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b0476859-07af-47f1-aec7-61aea0d99d24": {
      "match": "brand_token",
      "title": "ZALEPLON CAPSULE [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "8",
      "published_date": "2025-11-17"
    }
  },
  "productid": "71335-0236_2a582cd7-cb01-4ec4-bd0a-d43dcd56c31c",
  "productndc": "71335-0236",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "078989",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jun 6, 2008"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jun 6, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZALEPLON",
  "proprietary_name": "zaleplon",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078989",
  "marketing_category": "ANDA",
  "nonproprietary_name": "zaleplon",
  "start_marketing_date": "20090505",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N05CF03.

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