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United States · US · US:70518-1458_507111cb-975a-27ba-e063-6294a90a102c
Indomethacin
Orange BookUNIISPLATC C01EB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeC01EB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11705181458030 CAPSULE in 1 BLISTER PACK (70518-1458-0)
- ndc11705181458150 POUCH in 1 BOX (70518-1458-1) / 1 CAPSULE in 1 POUCH (70518-1458-2)
Annotations
UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A091276
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "XXE1CET956",
"rxcui": "5781",
"inchikey": "CGIGDMFJXJATDK-UHFFFAOYSA-N",
"display_name": "INDOMETHACIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"009097a5-2c1e-4f5d-8054-896cf896cb3d": {
"match": "brand_token",
"title": "INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "17",
"published_date": "2026-05-28"
}
},
"productid": "70518-1458_507111cb-975a-27ba-e063-6294a90a102c",
"productndc": "70518-1458",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "091276",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Dec 22, 2010"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Dec 22, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "INDOMETHACIN",
"proprietary_name": "Indomethacin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091276",
"marketing_category": "ANDA",
"nonproprietary_name": "Indomethacin",
"start_marketing_date": "20181003",
"active_numerator_strength": "25"
}Related drugs
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- GBFlexin-25 Continus tabletsNapp Pharmaceuticals Ltd
- GBFlexin-50 Continus tabletsNapp Pharmaceuticals Ltd
- GBFlexin-75 Continus tabletsNapp Pharmaceuticals Ltd
- GBIndocid 100mg suppositoriesNecessity Supplies Ltd
- GBIndocid 100mg suppositoriesAspen Pharma Trading Ltd
- GBIndocid 25mg capsulesOrganon Pharma (UK) Ltd
- GBIndocid 50mg capsulesOrganon Pharma (UK) Ltd
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