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 · 11

ndc11
7642088400
1000 CAPSULE in 1 BOTTLE (76420-884-00)
ndc11
7642088401
100 CAPSULE in 1 BOTTLE (76420-884-01)
ndc11
7642088407
7 CAPSULE in 1 BOTTLE (76420-884-07)
ndc11
7642088410
10 CAPSULE in 1 BOTTLE (76420-884-10)
ndc11
7642088412
12 CAPSULE in 1 BOTTLE (76420-884-12)
ndc11
7642088414
14 CAPSULE in 1 BOTTLE (76420-884-14)
ndc11
7642088420
20 CAPSULE in 1 BOTTLE (76420-884-20)
ndc11
7642088428
28 CAPSULE in 1 BOTTLE (76420-884-28)
ndc11
7642088430
30 CAPSULE in 1 BOTTLE (76420-884-30)
ndc11
7642088460
60 CAPSULE in 1 BOTTLE (76420-884-60)
ndc11
7642088490
90 CAPSULE in 1 BOTTLE (76420-884-90)

Annotations

UNII (FDA Substance ID)

927AH8112L

NITROFURANTOIN

RxCUI 7454

Orange Book

A211013

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": "76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b",
  "productndc": "76420-884",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211013",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG;25MG",
        "product_no": "001",
        "approval_date": "Feb 18, 2022"
      }
    ],
    "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": "ANDA211013",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
  "start_marketing_date": "20220222",
  "active_numerator_strength": "25; 75"
}

Related drugs

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