Nizatidine

Orange BookUNIISPLATC A02BA04

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

Identification

ManufacturerEpic Pharma, LLC

CountryUS (United States)

ATC codeA02BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4280630030
30 CAPSULE in 1 BOTTLE (42806-300-30)
ndc11
4280630060
60 CAPSULE in 1 BOTTLE (42806-300-60)

Annotations

UNII (FDA Substance ID)

P41PML4GHR

NIZATIDINE

RxCUI 42319

Orange Book

A076178

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "P41PML4GHR",
    "rxcui": "42319",
    "inchikey": "SGXXNSQHWDMGGP-UHFFFAOYSA-N",
    "display_name": "NIZATIDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e9957997-8b85-48a0-9bb3-b878cb223236": {
      "match": "brand_token",
      "title": "NIZATIDINE CAPSULE [EPIC PHARMA, LLC]",
      "spl_version": "1",
      "published_date": "2025-01-06"
    }
  },
  "productid": "42806-300_e9957997-8b85-48a0-9bb3-b878cb223236",
  "productndc": "42806-300",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076178",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jul 5, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jul 5, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NIZATIDINE",
  "proprietary_name": "Nizatidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076178",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nizatidine",
  "start_marketing_date": "20241025",
  "active_numerator_strength": "300"
}

Related drugs

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