🇺🇸
United States · US · US:68180-423_735f86f4-369c-4f5a-adbe-7dacea2e27b4
CEFIXIME
Orange BookUNIISPLATC J01DD08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01DD08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11681804230850 CAPSULE in 1 BOTTLE (68180-423-08)
- ndc1168180423111 BLISTER PACK in 1 CARTON (68180-423-11) / 10 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
97I1C92E55
CEFIXIME
RxCUI 25033
Orange Book
N203195
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "97I1C92E55",
"rxcui": "25033",
"inchikey": "IPYWNMVPZOAFOQ-NABDTECSSA-N",
"display_name": "CEFIXIME",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b5a3c547-3bc7-4856-af9c-1bead294f5d9": {
"match": "brand_token",
"title": "CEFIXIME TABLET [RISING PHARMA HOLDINGS, INC.]",
"spl_version": "3",
"published_date": "2026-04-13"
}
},
"productid": "68180-423_735f86f4-369c-4f5a-adbe-7dacea2e27b4",
"productndc": "68180-423",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "203195",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Jun 1, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFIXIME",
"proprietary_name": "CEFIXIME",
"active_ingred_unit": "mg/1",
"application_number": "NDA203195",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "CEFIXIME",
"start_marketing_date": "20201014",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J01DD08.
- CAAURO-CEFIXIMEAURO PHARMA INC
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- 🇪🇸CEFIXIMA MABO 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGMabo Farma S.A.
- 🇪🇸CEFIXIMA MABO 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGMabo Farma S.A.
- 🇪🇸CEFIXIMA NECLIFE 100 MG/5 ML POLVO PARA SUSPENSION ORAL EFGNeclife Pt Unipessoal Lda.
- 🇪🇸CEFIXIMA NORMON 200 mg CAPSULAS DURAS EFGLaboratorios Normon S.A.
- 🇪🇸CEFIXIMA NORMON 400 mg CAPSULAS DURAS EFGLaboratorios Normon S.A.
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