nitrofurantoin (macrocrystals)

In shortageOrange BookUNIISPLATC J01XE01

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeJ01XE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5965179501
100 CAPSULE in 1 BOTTLE (59651-795-01)

Annotations

UNII (FDA Substance ID)

927AH8112L

NITROFURANTOIN

RxCUI 7454

Orange Book

A077025

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Nitrofurantoin Oral Suspension

Raw payload (JSON)

{
  "unii": {
    "unii": "927AH8112L",
    "rxcui": "7454",
    "inchikey": "NXFQHRVNIOXGAQ-YCRREMRBSA-N",
    "display_name": "NITROFURANTOIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52eea406-abb9-2713-e063-6294a90a00c6": {
      "match": "brand_token",
      "title": "NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "59651-795_04053ba5-ceb5-4f34-9878-8abf1e552da2",
  "productndc": "59651-795",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077025",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 18, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Oct 2, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITROFURANTOIN",
  "shortage_reason": "Nitrofurantoin Oral Suspension",
  "shortage_status": "current",
  "proprietary_name": "nitrofurantoin (macrocrystals)",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077025",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nitrofurantoin (macrocrystals)",
  "start_marketing_date": "20230517",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code J01XE01.

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