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United States · US · US:71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a

nitrofurantoin macrocrystals

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 · 6

  • ndc11
    7133522541
    28 CAPSULE in 1 BOTTLE (71335-2254-1)
  • ndc11
    7133522542
    40 CAPSULE in 1 BOTTLE (71335-2254-2)
  • ndc11
    7133522543
    20 CAPSULE in 1 BOTTLE (71335-2254-3)
  • ndc11
    7133522544
    90 CAPSULE in 1 BOTTLE (71335-2254-4)
  • ndc11
    7133522545
    30 CAPSULE in 1 BOTTLE (71335-2254-5)
  • ndc11
    7133522546
    12 CAPSULE in 1 BOTTLE (71335-2254-6)

Annotations

UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A217272
ABABAB
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": "71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a",
  "productndc": "71335-2254",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "217272",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Mar 21, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Mar 21, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Mar 21, 2023"
      }
    ],
    "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 macrocrystals",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217272",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nitrofurantoin macrocrystals",
  "start_marketing_date": "20230321",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code J01XE01.

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