Nitrofurantoin (monohydrate/macrocrystals)

Orange BookUNIISPLATC J01XE

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeJ01XE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7642019501
100 CAPSULE in 1 BOTTLE (76420-195-01)
ndc11
7642019510
10 CAPSULE in 1 BOTTLE (76420-195-10)
ndc11
7642019514
14 CAPSULE in 1 BOTTLE (76420-195-14)
ndc11
7642019520
20 CAPSULE in 1 BOTTLE (76420-195-20)
ndc11
7642019530
30 CAPSULE in 1 BOTTLE (76420-195-30)
ndc11
7642019560
60 CAPSULE in 1 BOTTLE (76420-195-60)
ndc11
7642019590
90 CAPSULE in 1 BOTTLE (76420-195-90)

Annotations

UNII (FDA Substance ID)

927AH8112L

NITROFURANTOIN

RxCUI 7454

Orange Book

A077066

DailyMed SPL labels

1 version tracked

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": "76420-195_e9294cf2-886b-1f04-e053-2995a90a3984",
  "productndc": "76420-195",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077066",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG;25MG",
        "product_no": "001",
        "approval_date": "Apr 5, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
  "proprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA077066",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
  "start_marketing_date": "20050406",
  "active_numerator_strength": "25; 75"
}

Related drugs

Other records sharing ATC code J01XE.

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