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United States · US · US:70771-1318_40070531-4723-48f2-89b4-9efde4d1c71f
Phytonadione
Orange BookUNIISPLATC B02BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeB02BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1170771131811 BOTTLE in 1 CARTON (70771-1318-1) / 100 TABLET in 1 BOTTLE
- ndc11707711318330 TABLET in 1 BOTTLE (70771-1318-3)
- ndc11707711318410 BLISTER PACK in 1 CARTON (70771-1318-4) / 10 TABLET in 1 BLISTER PACK (70771-1318-2)
Annotations
UNII (FDA Substance ID)
A034SE7857
PHYTONADIONE
RxCUI 11258
Orange Book
A210189
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "A034SE7857",
"rxcui": "11258",
"inchikey": null,
"display_name": "PHYTONADIONE",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a4b394e7-b766-824e-a8bf-f56808de76e1": {
"match": "brand_token",
"title": "PHYTONADIONE INJECTION, EMULSION [XIROMED LLC]",
"spl_version": "2",
"published_date": "2026-04-09"
}
},
"productid": "70771-1318_40070531-4723-48f2-89b4-9efde4d1c71f",
"productndc": "70771-1318",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210189",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Feb 20, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHYTONADIONE",
"proprietary_name": "Phytonadione",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210189",
"marketing_category": "ANDA",
"nonproprietary_name": "Phytonadione",
"start_marketing_date": "20190222",
"active_numerator_strength": "5"
}Related drugs
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- CZKANAVITZentiva, k.s., Praha
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