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United States · US · US:10135-735_45222685-8d74-a7e1-e063-6294a90a9945
PYRAZINAMIDE
Orange BookUNIISPLATC J04AK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARLEX PHARMACEUTICALS, INC
CountryUS (United States)
ATC codeJ04AK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111013573501100 TABLET in 1 BOTTLE (10135-735-01)
- ndc11101357356060 TABLET in 1 BOTTLE (10135-735-60)
- ndc11101357359090 TABLET in 1 BOTTLE (10135-735-90)
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": "10135-735_45222685-8d74-a7e1-e063-6294a90a9945",
"productndc": "10135-735",
"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 tablet",
"start_marketing_date": "20220301",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J04AK01.
- FIIsopyratsinSchering Oy
- CAPDP-PYRAZINAMIDEPENDOPHARM DIVISION OF PHARMASCIENCE INC
- 🇪🇸PIRAZINAMIDA PRODES 250 mg COMPRIMIDOSKern Pharma S.L.
- 🇫🇷PIRILENE 500 mg, compriméSANOFI WINTHROP INDUSTRIE
- FIPyrazinamidPharmacal Oy Ab
- DKPyrazinamid "SAD"Amgros I/S
- PLPyrazinamid FarmapolPrzedsiębiorstwo Farmaceutyczne Farmapol Sp. z o.o.
- CZPYRAZINAMID KRKA
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