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United States · US · US:71610-395_10b9b8c8-0cfc-47b7-9324-bbd6f2617b5f
Isoniazid
In shortageOrange BookUNIISPLATC J04AC51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeJ04AC51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11716103953030 TABLET in 1 BOTTLE, PLASTIC (71610-395-30)
Annotations
UNII (FDA Substance ID)
V83O1VOZ8L
ISONIAZID
RxCUI 6038
Orange Book
A080937
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Isoniazid Tablet
Raw payload (JSON)
{
"unii": {
"unii": "V83O1VOZ8L",
"rxcui": "6038",
"inchikey": "QRXWMOHMRWLFEY-UHFFFAOYSA-N",
"display_name": "ISONIAZID",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e199dbfa-6d79-4c20-9984-9cd0c1907510": {
"match": "brand_token",
"title": "ISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]",
"spl_version": "13",
"published_date": "2026-05-20"
}
},
"productid": "71610-395_10b9b8c8-0cfc-47b7-9324-bbd6f2617b5f",
"productndc": "71610-395",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "080937",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "300MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ISONIAZID",
"shortage_reason": "Isoniazid Tablet",
"shortage_status": "current",
"proprietary_name": "Isoniazid",
"active_ingred_unit": "mg/1",
"application_number": "ANDA080937",
"marketing_category": "ANDA",
"nonproprietary_name": "Isoniazid",
"start_marketing_date": "19720901",
"active_numerator_strength": "300"
}Related drugs
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