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United States · US · US:50090-7660_7068c4e4-be9a-4750-b7b1-81b2753597d8

isoniazid

In shortageOrange BookUNIISPLATC J04AC51

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ04AC51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009076603
    30 TABLET in 1 BOTTLE (50090-7660-3)

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": "50090-7660_7068c4e4-be9a-4750-b7b1-81b2753597d8",
  "productndc": "50090-7660",
  "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": "20241015",
  "active_numerator_strength": "300"
}

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