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United States · US · US:0093-4137_7f269e55-b085-4315-807a-e425f0189b2c
Cefdinir
Orange BookUNIISPLATC J01DD15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeJ01DD15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11009341376460 mL in 1 BOTTLE (0093-4137-64)
- ndc110093413773100 mL in 1 BOTTLE (0093-4137-73)
Annotations
UNII (FDA Substance ID)
6E7SN358SE
CEFDINIR MONOHYDRATE
RxCUI 1306064
Orange Book
A065332
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6E7SN358SE",
"rxcui": "1306064",
"inchikey": "QWUVJQSNISEEQI-KYIYMPJCSA-N",
"display_name": "CEFDINIR MONOHYDRATE",
"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": "0093-4137_7f269e55-b085-4315-807a-e425f0189b2c",
"productndc": "0093-4137",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "065332",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "125MG/5ML",
"product_no": "001",
"approval_date": "May 4, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG/5ML",
"product_no": "002",
"approval_date": "May 4, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFDINIR MONOHYDRATE",
"proprietary_name": "Cefdinir",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA065332",
"marketing_category": "ANDA",
"nonproprietary_name": "Cefdinir",
"start_marketing_date": "20070508",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01DD15.
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