🇺🇸
United States · US · US:70518-4540_5070b8f5-b2f4-8d89-e063-6294a90adf72
isoniazid
In shortageOrange BookUNIISPLATC J04AC51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ04AC51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11705184540012 TABLET in 1 BOTTLE, PLASTIC (70518-4540-0)
- ndc11705184540130 TABLET in 1 BLISTER PACK (70518-4540-1)
Annotations
UNII (FDA Substance ID)
V83O1VOZ8L
ISONIAZID
RxCUI 6038
Orange Book
A040090
AAAA
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": "70518-4540_5070b8f5-b2f4-8d89-e063-6294a90adf72",
"productndc": "70518-4540",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040090",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jun 26, 1997"
},
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "300MG",
"product_no": "002",
"approval_date": "Jun 26, 1997"
}
],
"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": "ANDA040090",
"marketing_category": "ANDA",
"nonproprietary_name": "isoniazid",
"start_marketing_date": "20251223",
"active_numerator_strength": "300"
}Related drugs
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