🇺🇸
United States · US · US:68382-530_15c3b31f-e781-4406-a5b4-56c653ecff80
Diflunisal
Orange BookUNIISPLATC N02BA11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeN02BA11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc116838253001100 TABLET in 1 BOTTLE (68382-530-01)
- ndc116838253005500 TABLET in 1 BOTTLE (68382-530-05)
- ndc11683825300630 TABLET in 1 BOTTLE (68382-530-06)
- ndc1168382530101000 TABLET in 1 BOTTLE (68382-530-10)
- ndc11683825301460 TABLET in 1 BOTTLE (68382-530-14)
- ndc11683825301690 TABLET in 1 BOTTLE (68382-530-16)
- ndc11683825303010 BLISTER PACK in 1 CARTON (68382-530-30) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7C546U4DEN
DIFLUNISAL
RxCUI 3393
Orange Book
A203547
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7C546U4DEN",
"rxcui": "3393",
"inchikey": "HUPFGZXOMWLGNK-UHFFFAOYSA-N",
"display_name": "DIFLUNISAL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7a78bb38-14d8-4a90-b883-482d4cebf716": {
"match": "brand_token",
"title": "DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]",
"spl_version": "21",
"published_date": "2024-12-19"
}
},
"productid": "68382-530_15c3b31f-e781-4406-a5b4-56c653ecff80",
"productndc": "68382-530",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203547",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jun 16, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIFLUNISAL",
"proprietary_name": "Diflunisal",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203547",
"marketing_category": "ANDA",
"nonproprietary_name": "Diflunisal",
"start_marketing_date": "20170914",
"active_numerator_strength": "500"
}Related drugs
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- BEAttrogy 250 mgPurpose Pharma International
- IEAttrogy 250 mg film-coated tabletsAO Pharma AB
- NLAttrogy 250 mg filmomhulde tablettenAO Pharma AB
- FIDiflonidAlpharma ApS
- 🇺🇸diflunisalHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
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