🇺🇸
United States · US · US:68788-9405_558247ab-4b20-4398-9c35-51fa250acab0
Isoniazid
In shortageOrange BookUNIISPLATC J04AC51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ04AC51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116878894051100 TABLET in 1 BOTTLE (68788-9405-1)
- ndc11687889405330 TABLET in 1 BOTTLE (68788-9405-3)
- ndc11687889405660 TABLET in 1 BOTTLE (68788-9405-6)
- ndc11687889405990 TABLET in 1 BOTTLE (68788-9405-9)
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": "68788-9405_558247ab-4b20-4398-9c35-51fa250acab0",
"productndc": "68788-9405",
"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": "20141103",
"active_numerator_strength": "300"
}Related drugs
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