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United States · US · US:71335-1069_05e89273-b886-40bb-be42-7807d29f5dee

nitrofurantoin

In shortageOrange BookUNIISPLATC J01XE01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ01XE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    7133510691
    40 CAPSULE in 1 BOTTLE (71335-1069-1)
  • ndc11
    7133510692
    28 CAPSULE in 1 BOTTLE (71335-1069-2)
  • ndc11
    7133510693
    30 CAPSULE in 1 BOTTLE (71335-1069-3)
  • ndc11
    7133510694
    20 CAPSULE in 1 BOTTLE (71335-1069-4)
  • ndc11
    7133510695
    14 CAPSULE in 1 BOTTLE (71335-1069-5)
  • ndc11
    7133510696
    10 CAPSULE in 1 BOTTLE (71335-1069-6)
  • ndc11
    7133510697
    12 CAPSULE in 1 BOTTLE (71335-1069-7)
  • ndc11
    7133510698
    90 CAPSULE in 1 BOTTLE (71335-1069-8)
  • ndc11
    7133510699
    6 CAPSULE in 1 BOTTLE (71335-1069-9)

Annotations

UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A205005
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": "71335-1069_05e89273-b886-40bb-be42-7807d29f5dee",
  "productndc": "71335-1069",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205005",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Dec 12, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Dec 12, 2017"
      }
    ],
    "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205005",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nitrofurantoin macrocrystals",
  "start_marketing_date": "20180215",
  "active_numerator_strength": "100"
}

Related drugs

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