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United States · US · US:70518-2531_4a65bc05-7206-c088-e063-6294a90a9a3d
Macrobid
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11705182531010 CAPSULE in 1 BOTTLE, PLASTIC (70518-2531-0)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
N020064
AB
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": {
"28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e": {
"match": "brand_token",
"title": "MACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REMEDYREPACK INC.]",
"spl_version": "9",
"published_date": "2026-02-10"
}
},
"productid": "70518-2531_4a65bc05-7206-c088-e063-6294a90a9a3d",
"productndc": "70518-2531",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "020064",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "75MG;25MG",
"product_no": "001",
"approval_date": "Dec 24, 1991"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"proprietary_name": "Macrobid",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA020064",
"marketing_category": "NDA",
"nonproprietary_name": "Nitrofurantoin Monohydrate/Macrocrystalline",
"start_marketing_date": "20200108",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
- 🇺🇸MacrobidAlmatica Pharma LLC
- 🇺🇸NitrofurantoinST. MARY'S MEDICAL PARK PHARMACY
- 🇺🇸NitrofurantoinBryant Ranch Prepack
- 🇺🇸NitrofurantoinRedpharm Drug, Inc.
- 🇺🇸NitrofurantoinTrigen Laboratories, LLC
- 🇺🇸NitrofurantoinBryant Ranch Prepack
- 🇺🇸NitrofurantoinProficient Rx LP
- 🇺🇸NitrofurantoinPreferred Pharmaceuticals Inc.
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