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United States · US · US:71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc

Nitrofurantoin

Orange BookUNIISPLATC J01XE

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ01XE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    7133522551
    40 CAPSULE in 1 BOTTLE (71335-2255-1)
  • ndc11
    7133522552
    28 CAPSULE in 1 BOTTLE (71335-2255-2)
  • ndc11
    7133522553
    30 CAPSULE in 1 BOTTLE (71335-2255-3)
  • ndc11
    7133522554
    20 CAPSULE in 1 BOTTLE (71335-2255-4)
  • ndc11
    7133522555
    14 CAPSULE in 1 BOTTLE (71335-2255-5)
  • ndc11
    7133522556
    10 CAPSULE in 1 BOTTLE (71335-2255-6)
  • ndc11
    7133522557
    12 CAPSULE in 1 BOTTLE (71335-2255-7)
  • ndc11
    7133522558
    90 CAPSULE in 1 BOTTLE (71335-2255-8)
  • ndc11
    7133522559
    6 CAPSULE in 1 BOTTLE (71335-2255-9)

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": "71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc",
  "productndc": "71335-2255",
  "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

Other records sharing ATC code J01XE.

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