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United States · US · US:52427-285_83236f78-20ec-6005-4b09-cc2470a1b36a

Macrobid

Orange BookUNIISPLATC J01XE

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

Identification

ManufacturerAlmatica Pharma LLC
CountryUS (United States)
ATC codeJ01XE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5242728501
    100 CAPSULE in 1 BOTTLE (52427-285-01)

Annotations

UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
N020064
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": {
    "28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e": {
      "match": "brand_token",
      "title": "MACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REMEDYREPACK INC.]",
      "spl_version": "9",
      "published_date": "2026-02-10"
    }
  },
  "productid": "52427-285_83236f78-20ec-6005-4b09-cc2470a1b36a",
  "productndc": "52427-285",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "020064",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "75MG;25MG",
        "product_no": "001",
        "approval_date": "Dec 24, 1991"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
  "proprietary_name": "Macrobid",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA020064",
  "marketing_category": "NDA",
  "nonproprietary_name": "Nitrofurantoin Monohydrate/Macrocrystalline",
  "start_marketing_date": "20110531",
  "active_numerator_strength": "25; 75"
}

Related drugs

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