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United States · US · US:71205-380_eb67d441-028c-49e6-93b4-2be3b6bc9acf
Cefdinir
Orange BookUNIISPLATC J01DD15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01DD15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117120538000100 mL in 1 BOTTLE (71205-380-00)
- ndc11712053806060 mL in 1 BOTTLE (71205-380-60)
Annotations
UNII (FDA Substance ID)
CI0FAO63WC
CEFDINIR
RxCUI 25037
Orange Book
A065259
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "CI0FAO63WC",
"rxcui": "25037",
"inchikey": "RTXOFQZKPXMALH-GHXIOONMSA-N",
"display_name": "CEFDINIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a8029f7c-6353-46db-8c8c-c86a9485a14f": {
"match": "brand_token",
"title": "CEFDINIR CAPSULE [REMEDYREPACK INC.]",
"spl_version": "5",
"published_date": "2026-05-20"
}
},
"productid": "71205-380_eb67d441-028c-49e6-93b4-2be3b6bc9acf",
"productndc": "71205-380",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "065259",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "125MG/5ML",
"product_no": "001",
"approval_date": "May 31, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG/5ML",
"product_no": "002",
"approval_date": "May 7, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFDINIR",
"proprietary_name": "Cefdinir",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA065259",
"marketing_category": "ANDA",
"nonproprietary_name": "Cefdinir",
"start_marketing_date": "20070507",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01DD15.
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