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United States · US · US:67296-1442_2c6228e2-dbad-01e7-e063-6394a90acbbc

Nitrofurantoin

Orange BookUNIISPLATC J01XE

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

Identification

ManufacturerRedpharm Drug, Inc.
CountryUS (United States)
ATC codeJ01XE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6729614427
    14 CAPSULE in 1 BOTTLE (67296-1442-7)

Annotations

UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A208516
AB
DailyMed SPL labels
1 version tracked
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": "67296-1442_2c6228e2-dbad-01e7-e063-6394a90acbbc",
  "productndc": "67296-1442",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208516",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG;25MG",
        "product_no": "001",
        "approval_date": "May 24, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
  "proprietary_name": "Nitrofurantoin",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA208516",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nitrofurantoin",
  "start_marketing_date": "20180101",
  "active_numerator_strength": "25; 75"
}

Related drugs

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