Nitrofurantoin macrocrystals

In shortageOrange BookUNIISPLATC J01XE01

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

Identification

ManufacturerLupin Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeJ01XE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4338664201
100 CAPSULE in 1 BOTTLE (43386-642-01)

Annotations

UNII (FDA Substance ID)

927AH8112L

NITROFURANTOIN

RxCUI 7454

Orange Book

A203233

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": "43386-642_2e7ec48f-d605-4e97-8620-299e5f143026",
  "productndc": "43386-642",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "203233",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jul 9, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jul 9, 2018"
      }
    ],
    "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": "ANDA203233",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nitrofurantoin macrocrystals",
  "start_marketing_date": "20180709",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code J01XE01.

Access this data programmatically

Query Nitrofurantoin macrocrystals and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs