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United States · US · US:67877-547_662007e2-462e-4513-b5b0-efd5dcdc2421
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 · 2
- ndc116787754788100 mL in 1 BOTTLE (67877-547-88)
- ndc11678775479860 mL in 1 BOTTLE (67877-547-98)
Annotations
UNII (FDA Substance ID)
CI0FAO63WC
CEFDINIR
RxCUI 25037
Orange Book
A210534
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": "67877-547_662007e2-462e-4513-b5b0-efd5dcdc2421",
"productndc": "67877-547",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "210534",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "125MG/5ML",
"product_no": "001",
"approval_date": "Feb 19, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG/5ML",
"product_no": "002",
"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/5mL",
"application_number": "ANDA210534",
"marketing_category": "ANDA",
"nonproprietary_name": "cefdinir",
"start_marketing_date": "20210220",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code J01DD15.
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