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United States · US · US:67877-543_88df7b4a-ada5-4fd3-8e16-48053abdf1b2
Cefdinir
Orange BookUNIISPLATC J01DD15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeJ01DD15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116787754301100 CAPSULE in 1 BOTTLE (67877-543-01)
- ndc11678775433810 BLISTER PACK in 1 CARTON (67877-543-38) / 10 CAPSULE in 1 BLISTER PACK (67877-543-33)
- ndc11678775436060 CAPSULE in 1 BOTTLE (67877-543-60)
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": "67877-543_88df7b4a-ada5-4fd3-8e16-48053abdf1b2",
"productndc": "67877-543",
"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": "20210220",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J01DD15.
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