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United States · US · US:70771-1170_a2deefdc-9b32-44e4-a6bc-4eeae30e5c46

nitrofurantoin macrocrystals

In shortageOrange BookUNIISPLATC J01XE01

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeJ01XE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7077111700
    1000 CAPSULE in 1 BOTTLE (70771-1170-0)
  • ndc11
    7077111701
    100 CAPSULE in 1 BOTTLE (70771-1170-1)
  • ndc11
    7077111702
    10 BLISTER PACK in 1 CARTON (70771-1170-2) / 10 CAPSULE in 1 BLISTER PACK

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": "70771-1170_a2deefdc-9b32-44e4-a6bc-4eeae30e5c46",
  "productndc": "70771-1170",
  "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 macrocrystals",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205005",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nitrofurantoin macrocrystals",
  "start_marketing_date": "20180215",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code J01XE01.

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