isoniazid

In shortageOrange BookUNIISPLATC J04AC51

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMarlex Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ04AC51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1013580401
100 TABLET in 1 BOTTLE, PLASTIC (10135-804-01)

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": "10135-804_3e871908-abb7-9d35-e063-6394a90ac63d",
  "productndc": "10135-804",
  "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": "20250301",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code J04AC51.

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