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United States · US · US:0781-3056_66f2f4a4-1479-450c-8834-89cd29b08f2b

Isoniazid

In shortageOrange BookUNIISPLATC J04AC51

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeJ04AC51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0781305670
    1 VIAL, MULTI-DOSE in 1 CARTON (0781-3056-70) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
V83O1VOZ8L
ISONIAZID
RxCUI 6038
Orange Book
A040648
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": "INTRAMUSCULAR",
  "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": "0781-3056_66f2f4a4-1479-450c-8834-89cd29b08f2b",
  "productndc": "0781-3056",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "040648",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Jul 5, 2005"
      }
    ],
    "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/mL",
  "application_number": "ANDA040648",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isoniazid",
  "start_marketing_date": "20060119",
  "active_numerator_strength": "100"
}

Related drugs

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