Nitrofurantion

In shortageOrange BookUNIISPLATC J01XE01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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
7133500241
40 CAPSULE in 1 BOTTLE (71335-0024-1)
ndc11
7133500242
28 CAPSULE in 1 BOTTLE (71335-0024-2)
ndc11
7133500243
30 CAPSULE in 1 BOTTLE (71335-0024-3)
ndc11
7133500244
20 CAPSULE in 1 BOTTLE (71335-0024-4)
ndc11
7133500245
14 CAPSULE in 1 BOTTLE (71335-0024-5)
ndc11
7133500246
10 CAPSULE in 1 BOTTLE (71335-0024-6)
ndc11
7133500247
12 CAPSULE in 1 BOTTLE (71335-0024-7)
ndc11
7133500248
90 CAPSULE in 1 BOTTLE (71335-0024-8)
ndc11
7133500249
6 CAPSULE in 1 BOTTLE (71335-0024-9)

Annotations

UNII (FDA Substance ID)

927AH8112L

NITROFURANTOIN

RxCUI 7454

Orange Book

A201722

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": {
    "05f25774-f56a-48ef-bac3-8af663f8581a": {
      "match": "brand_token",
      "title": "NITROFURANTION CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "5",
      "published_date": "2026-04-08"
    }
  },
  "productid": "71335-0024_a9820123-e497-4bef-9246-474fe272142b",
  "productndc": "71335-0024",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "201722",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Feb 16, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Feb 16, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Feb 16, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITROFURANTOIN",
  "shortage_reason": "Nitrofurantoin Oral Suspension",
  "shortage_status": "current",
  "proprietary_name": "Nitrofurantion",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201722",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nitrofurantion",
  "start_marketing_date": "20160415",
  "active_numerator_strength": "100"
}

Related drugs

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