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United States · US · US:59651-206_30c5502b-09bd-4fd7-bec8-aba74d302e09

Nitrofurantoin

In shortageOrange BookUNIISPLATC J01XE01

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

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
    5965120623
    1 BOTTLE in 1 CARTON (59651-206-23) / 230 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
E1QI2CQQ1I
NITROFURANTOIN MONOHYDRATE
RxCUI 221129
Orange Book
A212607
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Nitrofurantoin Oral Suspension
Raw payload (JSON)
{
  "unii": {
    "unii": "E1QI2CQQ1I",
    "rxcui": "221129",
    "inchikey": "NHBPVLAHAVEISO-JSGFVSQVSA-N",
    "display_name": "NITROFURANTOIN MONOHYDRATE",
    "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": "59651-206_30c5502b-09bd-4fd7-bec8-aba74d302e09",
  "productndc": "59651-206",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "212607",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG/5ML",
        "product_no": "001",
        "approval_date": "May 11, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITROFURANTOIN MONOHYDRATE",
  "shortage_reason": "Nitrofurantoin Oral Suspension",
  "shortage_status": "current",
  "proprietary_name": "Nitrofurantoin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA212607",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nitrofurantoin",
  "start_marketing_date": "20230511",
  "active_numerator_strength": "25"
}

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