Nizatidine

Orange BookUNIISPLATC A02BA04

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

Identification

ManufacturerActavis Pharma, Inc.

CountryUS (United States)

ATC codeA02BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0591313830
30 CAPSULE in 1 BOTTLE, PLASTIC (0591-3138-30)

Annotations

UNII (FDA Substance ID)

P41PML4GHR

NIZATIDINE

RxCUI 42319

Orange Book

A075616

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": "0591-3138_0920fca7-e74b-49fb-809b-ef720690752e",
  "productndc": "0591-3138",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075616",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jul 9, 2002"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jul 9, 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": "ANDA075616",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nizatidine",
  "start_marketing_date": "20020709",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code A02BA04.

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