🇺🇸
United States · US · US:71335-2800_b2662f53-4b10-4d41-b868-3515e50d9956
Isoniazid
In shortageOrange BookUNIISPLATC J04AC51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ04AC51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117133528001100 TABLET in 1 BOTTLE (71335-2800-1)
- ndc11713352800230 TABLET in 1 BOTTLE (71335-2800-2)
- ndc11713352800360 TABLET in 1 BOTTLE (71335-2800-3)
- ndc11713352800435 TABLET in 1 BOTTLE (71335-2800-4)
- ndc11713352800590 TABLET in 1 BOTTLE (71335-2800-5)
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": "71335-2800_b2662f53-4b10-4d41-b868-3515e50d9956",
"productndc": "71335-2800",
"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": "20241101",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J04AC51.
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- 🇺🇸isoniazidBryant Ranch Prepack
- 🇺🇸isoniazidREMEDYREPACK INC.
- 🇺🇸isoniazidOMNIVIUM PHARMACEUTICALS LLC.
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- 🇺🇸isoniazidCoupler LLC
- 🇺🇸isoniazidMarlex Pharmaceuticals, Inc.
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