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United States · US · US:0904-7563_a0934baf-4745-4546-a63a-d4a660a188b3
Cefdinir
Orange BookUNIISPLATC J01DD15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeJ01DD15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1109047563043 BLISTER PACK in 1 CARTON (0904-7563-04) / 10 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
CI0FAO63WC
CEFDINIR
RxCUI 25037
Orange Book
A210220
AB
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": "0904-7563_a0934baf-4745-4546-a63a-d4a660a188b3",
"productndc": "0904-7563",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210220",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "001",
"approval_date": "Feb 19, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFDINIR",
"proprietary_name": "Cefdinir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210220",
"marketing_category": "ANDA",
"nonproprietary_name": "Cefdinir",
"start_marketing_date": "20251027",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J01DD15.
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