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United States · US · US:63187-835_5fcd955c-b46e-4949-b804-f81abe9d37b6
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
- ndc1163187835001 BOTTLE in 1 CARTON (63187-835-00) / 100 mL in 1 BOTTLE
- ndc1163187835601 BOTTLE in 1 CARTON (63187-835-60) / 60 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
CI0FAO63WC
CEFDINIR
RxCUI 25037
Orange Book
A065473
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": "63187-835_5fcd955c-b46e-4949-b804-f81abe9d37b6",
"productndc": "63187-835",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "065473",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "125MG/5ML",
"product_no": "001",
"approval_date": "Dec 14, 2007"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "250MG/5ML",
"product_no": "002",
"approval_date": "Dec 14, 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": "ANDA065473",
"marketing_category": "ANDA",
"nonproprietary_name": "Cefdinir",
"start_marketing_date": "20071214",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code J01DD15.
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