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United States · US · US:70954-484_e043f21d-4a30-4d23-bc03-12207af7d6d7

Pyrazinamide

Orange BookUNIISPLATC J04AK01

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ04AK01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7095448410
    60 TABLET in 1 BOTTLE (70954-484-10)
  • ndc11
    7095448420
    90 TABLET in 1 BOTTLE (70954-484-20)
  • ndc11
    7095448430
    100 TABLET in 1 BOTTLE (70954-484-30)

Annotations

UNII (FDA Substance ID)
2KNI5N06TI
PYRAZINAMIDE
RxCUI 8987
Orange Book
A080157
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2KNI5N06TI",
    "rxcui": "8987",
    "inchikey": "IPEHBUMCGVEMRF-UHFFFAOYSA-N",
    "display_name": "PYRAZINAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "262d8829-728c-48db-b89b-88d13b87e684": {
      "match": "brand_token",
      "title": "PYRAZINAMIDE TABLET [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-03-03"
    }
  },
  "productid": "70954-484_e043f21d-4a30-4d23-bc03-12207af7d6d7",
  "productndc": "70954-484",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "080157",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PYRAZINAMIDE",
  "proprietary_name": "Pyrazinamide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA080157",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pyrazinamide",
  "start_marketing_date": "20210511",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J04AK01.

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